Application Case of RT8 Transdermal Diffusion System——In Vitro Release Test of Gel Patches

Gel patch made by mixing the raw drug with a suitable hydrophilic matrix and laying it on the backing material. Gel patch has the advantages of high water content, good air permeability, large drug loading capacity, high absorption efficiency, no odor, and small skin irritation. It is more easily accepted by patients and clinicians, and has become one of the hot directions in the development of percutaneous drug delivery systems. Gel paste usually uses polymer material as the skeleton material, and then adds crosslinking agent, moisturizing agent, filler and transdermal enhancer to form a pseudoplastic fluid with a certain viscosity. During use, the drug components will be released from the skeleton material and reach the skin surface, and then enter the blood circulation through the epidermis to play a role. Therefore, the release rate and transdermal absorption rate of drug components of gel plaster will directly affect its clinical efficacy, and is an important quality index of gel plaster. Franz vertical diffusion cell method is generally used for in vitro release test (IVRT) and in vitro permeation test (ivpt) of gel paste. This article will share the in vitro release test case of a gel paste, hoping to bring you help and inspiration. Experimental Method Experimental Instrument: RT800 Automatic Sampling Transdermal Diffusion System Apparatus: Raytor improved Franz vertical diffusion cell Temperature: 32 ± 0.5 ℃ Medium: technical confidentiality Rotational Speed：300 RPM Medium Volume: 40 mL Sampling / Replenishment Volume: 1 ml Gel Paste Diameter: 16 mm Screening Filter Membrane In vitro release test of gel paste, appropriate inert and commercial artificial membrane will be selected. The permeation rate of the sample to be tested in different filter membranes may be different. When developing the method, the influence of the filter membrane on the release rate of the sample should be fully investigated. The following figure shows the in vitro release test results of gel paste samples under three filter membranes during the filter membrane screening process. After comprehensive consideration of other factors in the process of method development, it is decided to use filter membrane A as the test filter membrane. Experimental Result Through the early development of the method, the key parameters such as sample loading volume, filter membrane, medium, medium volume and rotation speed have been determined. In the subsequent stage, the accuracy, repeatability and discrimination of the test method were verified. According to the established method, the gel paste samples were tested for in vitro release. Then, according to USP <1724>, calculate the cumulative amount released per square centimeter area at each sampling time point: The test results are shown in the following figure. The abscissa of the cumulative drug release curve is the square root of time. The release of gel paste samples generally follows Higuch formula, that is, the cumulative drug release amount is proportional to the square root of time. The cumulative drug release of six test samples at each sampling time point was linearly regressed with the square root of the sampling time to obtain the regression equation and correlation coefficient, and the slope value was taken as the drug release rate constant. Results Discussion The results show that the Franz vertical diffusion cell method has high precision and good reproducibility. It can be applied to the in vitro release test of gel paste and provide valuable in vitro release measurement data for the formulation development of cream products. Thanks to the high-precision automatic design of RT800 automatic sampling transdermal diffusion system, the error introduced by the experimental system or manual operation is effectively reduced, making the repeatability of the test results more ideal.

Application Case of RT7 Flow-Through Cell Dissolution System ——Development of In Vitro Release Method Based on In Vivo Pharmacokinetic Data

As a more advanced dissolution method, the flow-through cell method has better discrimination and in vitro and in vivo correlation than the traditional dissolution method. With better instrument conditions, a suitable dissolution method is also very important. This research case is to cooperate with a customer to develop and optimize the flow-through cell method for in vitro release determination based on the in vivo pharmacokinetic data of a customer's product under development. The goal is to obtain the in vitro release test results that are related to the in vivo pharmacokinetic data. Dissolution System Flow-Through Cell Apparatus （USP  Apparatus 4): Raytor RT7 Flow-Through Cell Dissolution System Method Development Process Preliminary test results - no correlation with in vivo pharmacokinetic data According to the BE data of self-developed sample 1 and self-developed sample 2, the drug time curve of self-developed sample 1 is located on the Drug Concentration-Time Curve of the reference, and its C max and AUC are significantly higher than those of the reference; The Drug Concentration-Time Curve of self-developed sample 2 is below the drug time curve of the reference preparation, and its C max and AUC are lower than those of the reference preparation. However, there is no correlation between the preliminary in vitro release test results and in vivo pharmacokinetic data: (1) The release rate and cumulative dissolution of self-developed sample 2 were slightly higher than that of self-developed sample 1. (2) The in vitro release results of the reference and self-developed sample 2 are very similar, so it is impossible to effectively distinguish the difference between the two. In addition, in general, the in vitro release curves of the three samples were similar, and the method discrimination was not ideal. The preliminary test results are shown in the following figure: Through in-depth analysis of the in vitro release phenomena, test results and experimental parameters of the samples, we conclude that some experimental parameters of the flow-through cell method limit the real release of the samples. Furthermore, we redesigned the experimental method according to the release principle, dosage form and process characteristics of the sample. Test results related to in vivo pharmacokinetic data The in vitro release test results of the redesigned flow-through cell method meet the expected objectives of our experimental design: The release rate of self-developed sample 1 was faster than that of the reference, and the release rate of self-developed sample 2 was slower than that of the reference. The test results were correlated with the pharmacokinetic data in vivo. The test results are shown in the following figure: According to the in vitro release curve, we also found a small regret in the parameters of this method: although it can reflect the difference between the release of self-developed sample 2 and the reference, the difference between them is relatively small.  The difference between self-developed sample 1 and reference is more obvious. Reviewing the be data of self-developed sample 1 and self-developed sample 2, the difference between the in vivo pharmacokinetics data of self-developed sample 2 and the reference is indeed smaller than that of self-developed sample 1 and the reference. This further confirms that the new method is feasible and worthy of further optimization for better discrimination. For better discrimination In order to better distinguish the difference between the in vitro release of self-developed sample 2 and the reference preparation, we readjusted the test parameters, and investigated the influence of key parameters on the test results by controlling variables, such as pH value of dissolution medium, surfactant concentration, flow rate, glass bead filling amount at the bottom of flow-through cell, sample placement position, etc. After optimization of the above test parameters, the discrimination of in vitro release results is better, and there is still a correlation with in vivo pharmacokinetic data. The test results are shown in the following figure: Results and Discussion After redesigning the original flow-through cell dissolution method and optimizing the key parameters, the in vitro release results were correlated with the in vivo pharmacokinetic data, and the discrimination was good. This method development was able to meet the expected objectives of the experimental design, but also benefited from the full technical exchange with the client. The key information provided by the client, such as in vivo pharmacokinetic data, sample preparation process, design differences between different self-developed samples, makes the whole process of method development and optimization more targeted, and makes the final in vitro release test method and results have scientific logic and practical significance. The test results also confirmed once again that the flow-through cell method has the potential to predict the pharmacokinetic characteristics of drug substances, which can greatly boost the research, screening and optimization of preparation process, and make drug research and development more efficient.

Application Case of RT8 Transdermal Diffusion System -- In Vitro Release Test of Cream

Diffusion cell method is a reliable and reproducible method for in vitro release test (IVRT) of semi-solid dosage forms. The United States Pharmacopoeia (USP) < 1724 > SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS contains the specific determination methods and requirements of diffusion cell method. Cream is an ointment made of emulsion matrix. It has the characteristics of good drug release and penetration, improving local drug concentration and not hindering the normal function of skin. It is a commonly used dosage form in clinic. This article will share the in vitro release test case of an cream preparation using diffusion cell method, hoping to bring you help and inspiration. Test Method Experimental Instrument: RT800 Automatic Sampling Transdermal Diffusion System Apparatus: Raytor improved Franz vertical diffusion cell Temperature: 32 ± 0.5 ℃ Medium: technical confidentiality Rotational Speed：600 RPM Artificial Membrane: technical confidentiality Sample Loading Amount: ~ 0.3 g Medium Volume: 30 mL Sampling / Replenishment Volume: 1 ml Diffusion Cell Orifice Diameter: 15 mm Orifice Area of Diffusion Cell: 1.77 cm Testing Process Medium Volume Weigh the medium added to the diffusion cell, and calculate the volume of the medium according to the measured medium density: According to USP < 1724 >, all diffusion cells during the test shall have the same  volume, and the real volume of each diffusion cell shall be measured. Although USP < 1724 > does not explicitly require the error range of medium volume, we suggest that the error of medium volume should not exceed 1%. Sample Loading Amount Weigh and record the amount of cream in the sample loading ring, and make sure that the amount of cream is within the normal range. According to USP < 1724 >, the sample quantity tested by diffusion cell method is generally not less than 0.2g. Although the loading amount of the sample does not participate in the calculation of the cumulative drug release, the weighing data beyond the normal range can reveal possible abnormal sample loading, such as bubbles remaining between the cream and the filter membrane. Type of Membrane Appropriate inert and commercial artificial membranes should be selected for the in vitro release of semi-solid preparations. Commonly used membranes include polyethersulfone, cellulose acetate, nylon mixed ester and polytetrafluoroethylene membrane. Cellulose acetate is a hydrophilic membrane, which is not tolerant to organic solvents. Therefore, when the release medium contains organic solvents, the other three membranes are the better choice. Automatic Sampling According to USP < 1724 >, the sampling shall be completed within ± 2 min of the sampling time specified in the method. RT800 automatic sampling transdermal diffusion system can automatically complete the sampling of six diffusion cells at the same time, without the problem of sampling time difference. Test Result According to USP < 1724 >, calculate the cumulative amount released per 1 square centimeter of orifice area at each sampling time point: The relative standard deviation (RSD) of the cumulative release of six test samples in 24 hours is 1.53%. The repeatability of this test is good. The release of drugs in cream generally follows higuch formula, that is, the cumulative release of drugs is directly proportional to the square root of time. The cumulative drug release of six test samples at each sampling time point is linearly regressed with the square root of the sampling time to obtain the regression equation and correlation coefficient, and the slope value is taken as the drug release rate constant. Result Discussion The results show that the diffusion cell method has high precision and good reproducibility. It can be used to distinguish the differences of different cream formulations, and provide valuable in vitro release measurement data for the formulation development of cream products. Thanks to the high-precision automatic design of RT800 automatic sampling transdermal diffusion system, the error introduced by the experimental system or manual operation is effectively reduced, making the repeatability of the test results more ideal.

Application Case of Raytor Dissolution System——Study on In Vitro Release of Suspension Injection

Suspension injection, is a kind of preparation prepared by dispersing solid drugs in liquid for intramuscular or intravenous injection. Suspension injections generally increase the single dose and prolong the drug release time by reducing the drug solubility. At present, most FDA approved suspension injections have sustained drug release characteristics (from hours to days or weeks). At the same time, FDA believes that the high shear characteristics of traditional dissolution methods may lead to significant differences between the results of drug dissolution in vitro and pharmacokinetic behavior in vivo. In the FDA dissolution method database, the flow-through cell method with lower fluid shear force is included for the in vitro release test of a variety of suspension injections, such as betamethasone acetate / betamethasone sodium phosphate injection suspension, medroxyprogesterone acetate injection suspension, prednisolone acetate injection suspension, etc. This article will share a case study on the in vitro release of a suspension injection, and eva1uate the influence of different test conditions of paddle method and flow-through cell method on the in vitro release of suspension injection in the process of method development. Dissolution System Paddle Method（USP  Apparatus 2):  Raytor RT612-AT Automatic Sampling Dissolution System Flow-Through Cell Method（USP  Apparatus 4):  Raytor RT7 Flow-Through Cell Dissolution System Method Screening In the early screening process, we compared the in vitro release behavior of suspension injection under different test conditions of paddle method and flow-through cell method. The in vitro release results of each test condition are shown in the figure below (due to the technical confidentiality agreement, the specific parameters of the test conditions and dissolution medium will be omitted): The expected in vivo release time of this suspension injection is 12 hours. The high shear property of the paddle test results in the rapid release of the sample in vitro, which is different from the expected in vivo release time. In contrast, the flow-through cell method can provide a fluid environment closer to the drug release site. By adjusting the test parameters of the flow-through cell, we can obtain the dissolution curves of different release rates, such as Method A ~ Method C in the above figure. Then, according to the expected release time of the sample in vivo, we choose Method B as the basis for the next step of method optimization. Experimental Result After further optimizing the parameters of the method, the repeatability and discrimination of the test results of the flow-through cell method can meet the expectations of customers. Among them, take three batches of suspension injection samples (Lot A, Lot B, Lot C) with different production process as an example. Under the optimized test conditions, three batches of samples with different formation processes showed different in vitro release behavior. Through these differentiated in vitro release test results, we can effectively eva1uate the effects of different formation processes on the release of suspension injections. Result Discussion In the FDA dissolution method database, the in vitro release tests of suspension injections that can be queried basically use the flow-through cell method. It can be seen that the flow-through cell method has obvious technical advantages in the in vitro release test of suspension injection, which is difficult to be replaced by other dissolution methods. The low shear characteristic of the flow-through cell method makes the release time of the sample easier to coincide with the expectation in vivo, which can better reflect the release behavior of the suspension injection in a gentle fluid environment. Considering that there is no strong fluid shear force in the in vivo release environment of suspension injection, it can be predicted that the flow-through cell method can better eva1uate the in vivo release behavior of suspension injection. In addition, for suspension injection, the fluid shear force of dissolution method is lower, which also means that this method can have better discrimination, and it is easier to find the influence of different process parameters or different prescr1ption design on sample release, so as to provide good data support for preparation research and development and process prescr1ption optimization.

Application Case of Raytor Dissolution System ——In Vitro Release Test of Nanocrystalline Tablets

In nanocrystalline tablets, the API is generally nanocrystallized to a particle size of less than 1 μm particles. Through the nanocrystallization of API, the purposes of increasing solubility and dissolution, increasing adhesion to biofilm and reducing food interference can be achieved. For example, sirolimus is a new and efficient third-generation immunosuppressant. It is an immunosuppressant with low toxicity and great application potential. However, sirolimus has poor water solubility and low dissolution, which makes it difficult to be absorbed by human body and poor bioavailability. After nano treatment, it can effectively improve the problems of low solubility and low drug bioavailability. On the contrary, because the API will be nanosized to the particle size less than 1 μm, some nanocrystalline tablets will show a rapid release rate under the traditional dissolution method. Limited by the traditional dissolution method, the in vitro release test data may not be ideal. This paper will share the case of in vitro release test of a nanocrystalline tablet product using paddle method and flow-through cell method, and compare the difference between the traditional dissolution method (paddle method) and the more modern dissolution method (flow-through cell method) in the determination of nanocrystalline tablets. Experimental Method In order to control the variables in the test process, the experimental parameters of the two methods will be consistent as much as possible. For example, the paddle method and the flow-through cell method use the same sampling time point and dissolution medium. Due to the technical confidentiality agreement, the key parameters of the experimental method will be omitted in this paper. Paddle Method（USP  Apparatus 2) Dissolution System: Raytor RT612-AT Automatic Sampling Dissolution System Apparatus: Paddle Rotational Speed: 50 RPM Dissolution Medium Volume: 900 mL Temperature: 37.0 ± 0.5 ℃ Sampling Time Point: 5，10，15，20，25，30，40 min Flow-Through Cell Method（USP  Apparatus 4) Dissolution System: Raytor RT7 Flow-Through Cell Dissolution System Flow-through cell: 22.6mm inner diameter large cell Temperature: 37.0 ± 0.5 ℃ Sampling Time Point: 5，10，15，20，25，30，40 min Experimental Result Paddle Method（USP  Apparatus 2) The dissolution results of six samples tested in parallel by paddle method are as follows, and the relative standard deviation (RSD) of the final dissolution results is 0.86%: Flow-Through Cell Method（USP  Apparatus 4) The dissolution results of six samples tested in parallel by flow-through cell method are as follows, and the relative standard deviation (RSD) of the final dissolution results is 1.07%: Result Discussion As shown in the figure below, the dissolution rate of the nanocrystalline tablets under the test condition of paddle method is faster than that of flow-through cell method. For some nanocrystalline products with fast release rate, under the test conditions of paddle method, the method may have insufficient differentiation force or insufficient data to calculate the similarity factor due. In addition, from the analysis of fluid environment and filtration system, the flow-through cell method is also more advantageous than the paddle method. Fluid Environment The flow-through cell has a more gentle fluid environment than the paddle method, and the release rate of the sample will slow down significantly. Many literatures point out that the fluid environment of the flow-through cell will be closer to the fluid environment in the human gastrointestinal tract than the traditional dissolution method. For the paddle method, in order to prevent the particles generated in the sample release process from forming cone accumulation at the bottom of the dissolution vessel and affecting its release, it is generally necessary to ensure a rotational speed of at least 50rpm. If the rotational speed is further reduced, the risk of uneven mixing may also be introduced. According to the test results and relevant research literature, the fluid shear force of paddle method at 50 rpm is higher than that of flow-through cell method. Higher fluid shear force will accelerate the dissolution of the sample, and may also lose part of the discrimination. Filtration System The difference of filtration system between the two methods is also worth discussing. The front end of the sampling needle of traditional dissolution methods such as paddle method needs to be equipped with a cylindrical filter element to avoid pumping incompletely dissolved API particles into the pipeline system during sampling, resulting in abnormal results. At present, the minimum pore diameter of cylindrical filter element can only be 1 μm. However, the particle size of API in nanocrystalline tablets is less than 1 μm. Therefore, the traditional dissolution method is very likely to pump small API particles into the pipeline system in the sampling process of nanocrystalline tablets dissolution test. Although the needle filter with smaller aperture (disc filter) can be installed in the middle of the pipeline system or at the front end of the injection needle to block the API particles less than 1 μm , but this may also lead to the enrichment of API particles in the needle filter and re dissolution during sampling at subsequent time points, resulting in abnormal dissolution results. The filter chamber at the top of the flow-through cell can be equipped with filter membrane systems with various apertures, so as to ensure that the sample solution entering the sampling system from the flow-through cell has been effectively filtered. Tiny and undissolved API particles will be trapped in the flow-through cell until they dissolve into free API. In conclusion, the flow-through cell method has obvious advantages over the traditional dissolution method in terms of fluid environment and filtration system when testing the in vitro release of nanocrystalline tablets. We further recommend using the flow-through cell method to study the in vitro release of nanocrystalline tablets.

Application Case of RT7 Flow-Through Cell Dissolution System —— Study on In Vitro Release of Emulsion

Emulsion is an immiscible two-phase liquid, in which one phase is dispersed in the other phase in the form of small droplets. It is a non-uniform dispersed liquid preparation, which can be used for injection, oral administration and local administration. In vitro release is an important quality control index of emulsion, but the traditional dissolution method is difficult to meet the test requirements of in vitro release of emulsion: on the one hand, because the particle size of emulsion is small, the traditional dissolution method is difficult to separate the released API from the emulsion particles; On the other hand, the solubility of some drugs is relatively low, so it is difficult for the samples to be in the sink condition in the process of in vitro release. At present, many research literatures suggest that more modern methods can be used to determine the in vitro release of emulsion, such as flow-through cell method, dialysis method, sampling-separation method and so on. Among them, dialysis method may have the problem of very slow release rate (research shows that the release rate of emulsion determined by dialysis method is much slower than its real release rate in human body); The difficulty of sampling-separation method is how to effectively separate released API and emulsion particles, and the operation of this method is complex. As an alternative, the filtration system of flow-through cell method can separate the released API and emulsion particles without the problem of too slow release rate of dialysis method. This article will share the case of in vitro release determination of an emulsion, hoping to bring you help and inspiration. Experimental Method Flow-Through Cell Method（USP  Apparatus 4) Dissolution System: Raytor RT7 Flow-Through Cell Dissolution System Flow-Through Cell: Technical Confidentiality Test Parameters: Technical Confidentiality Sampling Time: 2.5，5，7.5，10，15，20 min Experimental Result Cumulative dissolution curve of Sample 1: Cumulative dissolution curve of Sample 2: The dissolution curves of Sample 1 and Sample 2 fit well, and the relative standard deviation (RSD) of the final dissolution rate are 0.54% and 0.79% respectively. The determination method has good repeatability. By comparing the average dissolution curves of the two samples, it can be found that the in vitro release rate of Sample 2 is faster than that of Sample 1. This method has good discrimination. Result Discussion The test results of this case show that the flow-through cell method can effectively determine the in vitro release of emulsion. Especially for some emulsion products with fast release speed, the flow-through cell method has shorter sampling interval and more accurate test results than dialysis method and sampling-separation method. In addition, in the process of method development, whether the dissolution medium meets the sink condition is also the key point to be concerned. The slow release rate of dialysis method is often caused by the failure of this test method to meet the conditions of sink condition. After the emulsion is added into the dialysis bag, the volume of dissolution medium in the dialysis bag is limited, and in most cases it will not reach the sink condition. At this time, most drugs are still in the oil phase particles, and only a few API can be released into the water phase, and the release process is relatively slow. In addition, the contact area of the emulsion release process is only the surface area of the dialysis bag, which is much smaller than the total surface area of the dispersed particles in the emulsion. The low concentration of the initial aqueous phase drug and the small release contact area eventually lead to the slow and incomplete release of the emulsion sample. In addition, there is also an upper limit on the volume of dissolution medium in the sampling-separation method, while there is no upper limit in theory for the volume of dissolution medium in the flow-through cell method. Therefore, under the same test conditions, the flow-through cell method can obtain better sink conditions than dialysis method and sampling-separation method, and is more suitable for the determination of in vitro release of emulsion containing insoluble drugs.

Flow-Through Cell Dissolution System

Raytor RT7 Flow-Through Cell Dissolution System Raytor RT7 Flow-Through Cell Dissolution System includes: Flow-Through Cell Dissolution Apparatus, Medium Conveying Workstation and Automatic Sampling Workstation. It can be upgraded to UV or HPLC online detection, and can be upgraded to be used in conjunction with the permeation system. The design and performance of RT7 Flow-Through Cell Dissolution System meet the requirements of the sixth method for determination of dissolution and release in Chinese Pharmacopoeia 2020, USP dissolution apparatus 4 and European Pharmacopoeia dissolution apparatus 4.  A single RT7 Flow-Through Cell Dissolution System can simply switch between closed-loop method and open-loop method without replacing the automatic sampling workstation, so as to meet the needs of various samples corresponding to different flow-through cell methods. Flow-Through Cell Dissolution Apparatus The 7-channel (or 8-channel) flow-through cell apparatus can be adapted to various Pharmacopoeia standard flow-through cells . At the same time, Raytor Instruments provides customized flow-through cell service to further meet the flow-through cell dissolution test of various special samples. Each flow-through cell channel has an independent temperature sensor. Teflon pipe with high chemical stability and high adsorption resistance is adopted. Effectively avoid corrosion of  pipe system or sample adsorption. Medium Conveying Workstation It is used to preheat and stir the dissolution medium, and transport the medium to the flow-throuhg cell by a high-precision constant flow pump. Integrated Water Bath Heating & Stirring Device The 8-position magnetic stirring device can meet the experimental requirements of 7 sample medium vessels +1 replenishment medium vessel in closed-loop mode. High Precision Injection Pump The user can preset the flow rate of dissolution method. The flow rate mode can be selected as no pulse mode or pulse mode. Flow rate  error ＜± 5%. In pulse mode, the error of pulse frequency is less than ± 10 impulse / min. Automatic Sampling Workstation One automatic sampling workstation can meet the sampling requirement of closed loop method or open loop method. In open loop mode, interval sampling, continuous sampling or split ratio sampling can be selected. Teflon pipe with high chemical stability and high adsorption resistance is adopted. Effectively avoid corrosion of  pipe system or sample adsorption. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion

Automatic Sampling Reciprocating Cylinder Dissolution System

Raytor RT3-AT Reciprocating Cylinder Automatic Sampling Dissolution System includes Raytor RT3 Reciprocating Cylinder Dissolution Apparatus and Raytor Automatic Sampling Workstation. Raytor RT3 Reciprocating Cylinder Dissolution Apparatus has stable performance and fully meets the requirements of Chinese Pharmacopoeia, US Pharmacopoeia and European Pharmacopoeia for reciprocating cylinder dissolution test. RT3 is equipped with 7 reciprocating cylinder units and 6 rows of dissolution vessels. It can use a variety of dissolution media with different pH at the same time to effectively simulate the human gastrointestinal environment. At the same time, RT3 has advanced automation design, including automatic replacement of dissolution medium and automatic opening of dissolution vessel cover, which makes the dissolution experiment more efficient and accurate. Raytor Automatic Sampling Workstation is equipped with 7-channel high-precision ruituo syringe pump, which has the functions of automatic wetting and washing pipe, automatic sampling and liquid replenishment, and automatic emptying pipe after sampling. Effectively provide accurate and precise sampling at each sampling time point, reflecting the advantages of high efficiency, accuracy, stability and easy use of software. Raytor RT3 Reciprocating Cylinder Dissolution Apparatus Reciprocating Lifting Motor The reciprocating rate (4 ~ 60 DPM), reciprocating stroke (2 ~ 10 cm), immersion time and drain time can be set. Automatic Displacement Motor According to the time interval set by the method, it will automatically transfer the reciprocating cylinder to the next row of dissolution vessel. Automatic Dissolution Vessel Cover The cover of dissolution vessel can automatically open and close, effectively reduce the evaporation loss of the dissolution medium. Reciprocating Cylinder Rack Clean the used reciprocating cylinders and place them on the rack for drying, which is convenient for the next experiment. Automatic Positioning Sampling Needles According to the volume of dissolution medium set by the method, the sampling needles will automatically position to the midpoint from the bottom of the vessel to the liquid level. Reciprocating Cylinder Mounting Bracket The coaxial split design makes it quickly to replace the reciprocating cylinder with other reciprocating holder. User-Computer Interface 8.4-inch touch screen, pre installed with the Raytor dissolution operating system, meeting the data integrity requirements. Integral Moulding Water Bath Integrated moulding and rounded angle design, no cleaning dead angle, water bath can be completely drained. Flexible Sampling Scheme  RT3 provides flexible sampling scheme. Even if there is no automatic sampling workstation, the user can perform the manually sampling through thesampling hole on the dissolution apparatus. Raytor Automatic Sampling Workstation Teflon sampling pipeline with high chemical stability and high adsorption resistance is adopted to avoid corrosion or adsorption of pipe. Before sampling, moisten the sampling pipe and return pipe to make the sample concentration more accurate. After sampling, purge and empty the residual liquid in the sampling pipe, return pipe and sample injection needle to make the sampling volume more accurate. It has the function of automatically replenishing medium and automatically cleaning pipe. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

12 Vessels Manual Sampling Dissolution Apparatus

Raytor RT612 Manual Sampling Dissolution Apparatus Raytor RT612 Dissolution Apparatus is a high-performance 12 vessels dissolution apparatus newly designed and manufactured in accordance with the requirements of Chinese Pharmacopoeia, USP Pharmacopoeia and guiding principles for mechanical verification of drug dissolution apparatus. It has accurate mechanical parameters, stable performance, and has an operating system that fully meets the data integrity, which is suitable for various standardized dissolution tests. Automatic Synchronous Dosing The automatic dosing module can realize the automatic synchronous dosing of all samples, and the dosing time point can be recorded and audited by the system. After dosing, the sampling time will be timed automatically, and a prompt will sound before reaching the sampling time point. Flexible and Accurate Sampling Automatic positioning of sampling position: the system automatically locates the sampling position of the sampling needle according to the preset experimental method (basket method / paddle method, etc.) and the volume of dissolution medium. The non resident sampling needle reduces the generation of disturbance of dissolved medium during the test. Flexible sampling mode, supporting automatic sampling and manual sampling: Automatic Sampling: when an automatic sampling workstation is configured, automatic sampling can be carried out at the preset sampling time point through the automatic sampling workstation. Manual Sampling: manual sampling can be carried out through the sampling port reserved on the anti evaporation cover, or manual sampling can be carried out by using the automatic positioning sampling needle. Patent Design of Common Shaft for Paddle and Basket The dissolution stirring parts of basket method, paddle method and small vessel method are designed in common shaft. The dissolution stirring parts such as basket method / paddle method can be switched freely on the same rotating shaft without repositioning, which is accurate and convenient and saves a lot of experimental time. The connection between the dissolution stirring part and the rotating shaft is located above the liquid level of the dissolution medium, which is easy to clean and has no residual risk. The dissolution stirring parts are made of 316L stainless steel and have special anti-corrosion coating treatment, which can effectively deal with various experimental conditions. Edge Wrapped Design of Dissolution Vessel The edge of the Raytor dissolution vessel adopts an innovative edge wrapping design, which effectively avoids the possible collision damage of the dissolution vessel during use, making the dissolution vessel more durable. Quick and accurate installation of dissolution vessel: align the three convex buckles of dissolution vessel with the three concave positions of the hole on the base of the installation platform, put it into the dissolution vessel, and rotate it clockwise for 30 ° to complete the installation. The traditional fixed spring buckle of dissolution vessel is eliminated, and the integrated and flat installation platform of dissolution vessel is very convenient for cleaning.   Advanced Mechanical Component Design The driving head adopts intelligent automatic lifting mode: the dissolution apparatus drives the head to lift accurately and reliably to ensure that the key experimental parameters such as the height and center position of the shaft have high accuracy and reproducibility. The high-definition wide touch screen clearly presents the experimental process and test parameters for easy operation. The non resident temperature probe monitors the temperature of the dissolved medium at each preset sampling time point. The water bath adopts integrated fillet design: the water bath cycle has no dead corner and constant temperature ability; There is no cleaning dead corner, and the water bath drain is located at the bottom of the water bath, which can ensure that the water bath can be completely drained. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

8 Vessels Manual Sampling Dissolution Apparatus

Raytor RT600 Manual Sampling Dissolution Apparatus Raytor RT600 Dissolution Apparatus is a high-performance 8 vessels dissolution apparatus newly designed and manufactured in accordance with the requirements of Chinese Pharmacopoeia, USP Pharmacopoeia and guiding principles for mechanical verification of drug dissolution apparatus. It has accurate mechanical parameters, stable performance, and has an operating system that fully meets the data integrity, which is suitable for various standardized dissolution tests. Automatic Synchronous Dosing The automatic dosing module can realize the automatic synchronous dosing of all samples, and the dosing time point can be recorded and audited by the system. After dosing, the sampling time will be timed automatically, and a prompt will sound before reaching the sampling time point. Flexible and Accurate Sampling Automatic positioning of sampling position: the system automatically locates the sampling position of the sampling needle according to the preset experimental method (basket method / paddle method, etc.) and the volume of dissolution medium. The non resident sampling needle reduces the generation of disturbance of dissolved medium during the test. Flexible sampling mode, supporting automatic sampling and manual sampling: Automatic Sampling: when an automatic sampling workstation is configured, automatic sampling can be carried out at the preset sampling time point through the automatic sampling workstation. Manual Sampling: manual sampling can be carried out through the sampling port reserved on the anti evaporation cover, or manual sampling can be carried out by using the automatic positioning sampling needle. Patent Design of Common Shaft for Paddle and Basket The dissolution stirring parts of basket method, paddle method and small vessel method are designed in common shaft. The dissolution stirring parts such as basket method / paddle method can be switched freely on the same rotating shaft without repositioning, which is accurate and convenient and saves a lot of experimental time. The connection between the dissolution stirring part and the rotating shaft is located above the liquid level of the dissolution medium, which is easy to clean and has no residual risk. The dissolution stirring parts are made of 316L stainless steel and have special anti-corrosion coating treatment, which can effectively deal with various experimental conditions. Edge Wrapped Design of Dissolution Vessel The edge of the Raytor dissolution vessel adopts an innovative edge wrapping design, which effectively avoids the possible collision damage of the dissolution vessel during use, making the dissolution vessel more durable. Quick and accurate installation of dissolution vessel: align the three convex buckles of dissolution vessel with the three concave positions of the hole on the base of the installation platform, put it into the dissolution vessel, and rotate it clockwise for 30 ° to complete the installation. The traditional fixed spring buckle of dissolution vessel is eliminated, and the integrated and flat installation platform of dissolution vessel is very convenient for cleaning.   Advanced Mechanical Component Design The driving head adopts intelligent automatic lifting mode: the dissolution apparatus drives the head to lift accurately and reliably to ensure that the key experimental parameters such as the height and center position of the shaft have high accuracy and reproducibility. The high-definition wide touch screen clearly presents the experimental process and test parameters for easy operation. The non resident temperature probe monitors the temperature of the dissolved medium at each preset sampling time point. The water bath adopts integrated fillet design: the water bath cycle has no dead corner and constant temperature ability; There is no cleaning dead corner, and the water bath drain is located at the bottom of the water bath, which can ensure that the water bath can be completely drained. The Operating System Fully Compliant with Data Integrity  Software System: the software system is simple to operate and easy to use; At least 200 dissolution test methods can be stored; The storage capacity of the system can meet the record storage for at least 10 years. User Authority Management: at least 100 login accounts can be preset and protected by user login password; At least 3 kinds of user permissions can be assigned (system administrator, laboratory supervisor and experimental analyst); Users can flexibly customize the permission details of various permission levels according to their own risk assessment. Audit Track: the audit track function specific to individual accounts at all levels, including login records, experiment records, operation records, cleaning records, etc. Electronic Data Integrity: accurate and consistent electronic data can be generated synchronously during experiments. Each experiment will automatically generate corresponding experimental records and support PDF format export. Experimental records and all records of the system can be retrieved, exported, backed up and printed. All electronic data are protected from arbitrary tampering and deletion.

Invitation of Raytor Lecture- "Preparation Strategy of Insoluble Drugs"

Time: September 15, 2022 (Thursday) 19：30-20：30 Location: Raytor Instruments Knowledge Store (online) Scan code for registration (company / name / contact information) Course Introduction Professor Han Jun, the famous dean of the Institute of Biological Preparations of Liaocheng University and Taishan scholar, was invited to share the preparation strategies for insoluble drugs for pharmaceutical colleagues in this Raytor Lecture. We hope to bring you a better idea of innovative preparation development. Trainer Introduction Professor Han Jun Professor Han Jun, Dean of Biopharmaceutical Research Institute of Liaocheng University, Distinguished Expert of National Major Talent Program, Doctoral Supervisor of Shandong Normal University and Jinan University, Distinguished Professor (Grade II) of "Taishan Scholar" in Shandong Province, Bachelor of Pharmacy of the Second Military Medical University, Doctor of Pharmacy of the University of Minnesota in the United States, and General Manager of Liaocheng Hi tech Biotechnology Co., Ltd Academic member of the Key Laboratory for Research and eva1uation of Generic Drugs (Jinan) of the State Drug Administration, academic member of the National Key Laboratory for Algae Active Substances (Qingdao), and former chief scientist of the National Key Laboratory for Antibody Drugs and Targeted Therapy (Shanghai). Professor Han led the construction of Shandong Antibody Pharmaceutical Collaborative Innovation Center and Shandong Nanodrug and Drug Release System Engineering Technology Research Center in Liaocheng University, and served as the director of the center. At present, he has presided over and participated in many national, provincial and ministerial projects, including the national "major new drug discovery" science and technology major project, and has project cooperation and academic exchanges with dozens of international and domestic enterprises and research institutions. Professor Han has worked and lived in the United States for more than 20 years. He once worked in Sanofi, Pfizer, Abbott, Novartis, Teva and other international pharmaceutical enterprises. Responsible for and participated in the R&D and marketing of dozens of new drugs and hundreds of generic drugs (America), and served as the founding president and the first chairman of the Board of Directors of the American Chinese Biomedical Association (CABA) in Boston.

Brief Introduction：Operation of RT7 Flow-Through Cell Dissolution System