-Shenzhen Ruituo Instrument Equipment Co., Ltd

2022-09-21

RT806 Vertical Transdermal Diffusion Apparatus

Raytor RT806 Vertical Transdermal Diffusion Apparatus meets the requirements of USP <1724>, which is used for drug transdermal release test of ointment, hard paste, coating, lotion, membrane, aerosol and other preparations, and studies the efficiency of drug transdermal absorption through the skin through the model of percutaneous absorption. RT806 can adapts to Raytor improved Franz vertical diffusion cell. Advanced dry heating stirring system, with adjustable heating temperature and mixing rotational speed. The sampling mode is manual sampling. RT806 Vertical Transdermal Diffusion Apparatus Raytor Improved Franz Vertical Diffusion Cell More portable and durable, the unique sampling arm design makes the sampling process more convenient and smooth. Dry Heating Stirring System The medium in the diffusion cell will be heated and mixed by dry heating and magnetic stirring. Control Panel It is used to set the heating temperature and stirring speed, and control the start or stop of heating and stirring. Temperature Measuring Probe It is used to measure the temperature of the medium in the vertical diffusion cell. Adjust the heating temperature and stirring speed through the knob. The set value and current value of heating temperature and stirring speed will be displayed on the screen in real time. Install the vertical diffusion cell filled with medium on the dry heating stirring base. Start heating and stirring to preheat the medium. Use the temperature measuring probe to measure the temperature of the medium in each vertical diffusion cell to ensure that the medium temperature has reached the specified value and remains stable. Stop stirring, add the sample to the donor chamber assembly above the vertical diffusion cell, eliminate bubbles, restart stirring, and start the experiment. Conduct manual sampling through the sampling arm at the specified time point. The donor chamber component of the vertical diffusion cell has two dosing modes: pseudo-infinite dosing or dosing with quantitative ring. Sample loading can be changed by using the quantitative ring with different thickness. Raytor provide vertical diffusion cells of different sizes, and the volume of media can be adjusted by using stirring bars of different heights.

2022-07-04

Invitation of Raytor Lecture- "Interpretation of In Vivo and In Vitro Correlation and BE Exemption"

Time: July 6, 2022 (Wednesday) 19：30-20：30 Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4+7 volume procurement, more and more pharmaceutical enterprises improve their profitability by developing innovative preparations, and more and more enterprises recognize the important role of in vivo and in vitro correlation and BE exemption in reducing their R & D costs. However, many enterprises are worried that the relevant research will not be supported at the regulatory level. In this issue, Raytor Lecture will invite Dr. Guo Yonghui, a well-known expert from the provincial drug inspection institute and national GMP inspector, to share his views on in vivo and in vitro correlation and BE exemption from the perspective of national regulations. Trainer Introduction Dr. Guo Yonghui Experts from the drug inspection institute and national GMP inspectors. Worked in provincial drug inspection institutes, participated in the preparation of Chinese Pharmacopoeia, national GMP inspector, and registered inspector. He is a new drug review expert and serves as the R & D Quality Consultant of many pharmaceutical enterprises.

2022-06-09

Invitation of Raytor Lecture- "In Vitro and In Vivo Correlation of Oral Solid Preparations"

Time: June 8, 2022 (Wednesday)19：30-20：30 Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4+7 volume purchasing, more and more pharmaceutical enterprises expect to improve their profitability by developing products with the same efficacy as the original drug. However, in the actual drug development work, many pharmaceutical peers often find that even if the four dissolution curves are consistent with the reference, there may still be a problem that there is no correlation between the in vivo pharmacokinetic data and the in vitro release test results at BE test. Therefore, in this Raytor lecture hall, we specially invite Mr. Meng Guangdong, deputy general manager of Wanbang Pharmaceutical Technology Co., Ltd., a well-known drug cro company, to discuss with you the topic of in vivo and in vitro correlation of oral solid preparations. Trainer Introduction Meng Guangdong, deputy general manager of Anhui Wanbang pharmaceutical, has been engaged in drug research and development for 18 years, and has presided over the research, development and application of more than 60 pharmaceutical projects. Jacky Lu, technical director of Raytor Instruments, graduated from the Department of biochemistry of Sun Yat sen University, has worked in Takeda, Baxter, pharmdex and other multinational enterprises for more than 10 years, and has a deep understanding of drug analysis and drug quality research.

2022-03-29

Invitation of Raytor Lecture- "Study on In Vitro Release of Oral Nanocrystalline Drugs by Flow-Through Cell Method"

Time: Thursday, April 7, 2022 19：30-20：30 Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4 + 7 volume procurement, more and more pharmaceutical enterprises improve their profitability by developing innovative preparations. In this course, Raytor Instruments will take oral nanocrystalline drugs as the representative dosage form to study the dissolution of nanocrystalline drugs in vitro by flow-through cell method, so as to provide innovative dissolution solutions for domestic scientific researchers. The main contents of this course include: 1. Statement for experimental data. 2. Development of oral nanocrystalline drugs. 3. Regulatory requirements for the development of oral nanocrystalline drugs. 4. In vitro dissolution of oral nanocrystalline drugs. 5. Next course introduction. 6. Q & A (10 minutes) Trainer Introduction Jacky Lu Technical director of Raytor Instruments, graduated from the Department of Biochemistry of Sun Yat Sen University, has worked in Takeda, Baxter, Pharmdex and other multinational enterprises for more than 10 years, and has a deep understanding of drug analysis and drug quality research.

2022-02-12

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

Eye drops are currently the most commonly used dosage form for the treatment of eye diseases, but they will quickly lose from the eye surface, and their drug bioavailability is usually less than 5%. The use of in-situ gel as an ophthalmic drug delivery system can prolong the retention time of drugs in the eyes, reduce the frequency of drug delivery, improve the bioavailability, and achieve the goal of sustained release. In situ gel is in liquid state in vitro. After administration, the drug will change at the drug site due to temperature, pH value and ionic strength. It will transform from liquid to non chemical crosslinking semisolid gel. In situ gel can be classified as temperature sensitive, pH sensitive and ionic sensitive. In recent years, the application of ophthalmic gel in ophthalmic drug delivery system has been highly valued by drug researchers. However, due to the specificity of its dosage form, how to effectively study the in vitro release of ophthalmic gel has always been a technical problem. This article will share the case of using the RT7 Flow-Through Cell Dissolution System to study the in vitro release of ophthalmic gel, hoping to help and inspire you. Experimental Method Flow-Through Cell (USP Apparatus 4) Dissolution System: Raytor RT7 Flow-Through Cell Dissolution System Flow-Through Cell: 22.6mm inner diameter pharmacopoeia standard cell Test parameters: technical confidentiality Sampling time point: 5，10，20，30，60，90，120，180，240 min Experimental Result The following is an in vitro release curve of two different production processes (Sample 1 and Sample 2) of an eye gel, and the average result of parallel test data is obtained from the test results. The repeatability of the test results is good. The relative standard deviations of the final dissolution rates of Sample 1 and Sample 2 are 0.66% and 0.88% respectively. In addition, the test results show that the flow-through cell test method and its conditions can distinguish the difference of release degree between different production process batches. We can clearly observe that Sample 2 releases faster than Sample 1. Result Discussion Ophthalmic in situ gel preparation is liquid at room temperature. After taking medicine, it turns into non chemical crosslinking semisolid gel in the eye, and releases the main ingredient slowly and slowly. Therefore, how to sample the liquid in the in vitro release measurement, how to ensure that the liquid state samples can be completely transformed into semisolid gel, how to make semi-solid gel samples release in a more gentle and more similar environment, and how to reflect the slow release process of samples. These are all considerations for the development of ophthalmic gel in vitro release assay. With the in-depth and mature research of the flow-through cell, we can study the in vitro release of more and more special durg such as ophthalmic gel formulations. Thanks to the advantages of flow-through cell method, we can get rid of the constraints of traditional dissolution methods and make the determination of in vitro release more meet the expectations of drug developers for the test results.

2022-01-13

Application case of RT3 Reciprocating Cylinder Dissolution System -- In Vitro Release Test of Soft Candy Preparation

Soft candy is a kind of dosage form with high moisture content, softness, elasticity and toughness. Nutritional soft candy or therapeutic soft candy can be made by adding nutritional components or therapeutic drugs to soft candy. The main characteristic of soft candy is that they contain different kinds of colloids, so that they have gel properties. Traditional dissolution methods may not be able to normally investigate the release behavior of soft candy in vitro, because soft candy will be insoluble as a whole. This article will share the case of using the reciprocating cylinder dissolution system to determine the in vitro release of soft candy preparations, hoping to bring you help and inspiration. Experimental Method Reciprocating cylinder method（USP Apparatus 3) Dissolution system: Raytor RT3-AT reciprocating cylinder automatic sampling dissolution system Volume of dissolution medium: 250 mL Temperature: 37.0 ± 0.5 ℃ Reciprocating stroke: 10 cm Experimental Result This case summarizes the in vitro release results of two soft candy preparations, and draws the cumulative dissolution rate time curve respectively: Soft candy preparation A Soft candy preparation B Both types of soft candy can be completely dissolved under the corresponding test conditions of reciprocating cylinder method. The relative standard deviation of the final dissolution result of soft cand preparation A in 120 min was 1.0%; The relative standard deviation of the final dissolution result of soft cand preparation B in 60 min was 1.1%. The repeatability of the test results is good. Result Discussion In soft candy, there is a network structure synthesized by linear colloidal knot, which forms the skeleton of soft candy. These reticular or dendritic skeleton structures are filled with various substances such as water, various excipients and main drug components. If need to effectively release various material components in the skeleton, the skeleton structure in the soft candy need to be opened. However, the fluid shear force generated by the traditional dissolution method is not enough to effectively open these skeleton structures, and the soft candy may only show a swelling state. The reciprocating cylinder method can provide greater fluid shear force. The framework structure of fudge is gradually opened with the reciprocating fluid shear force up and down, and the contents are gradually dissolved until they are completely released. In addition, some studies have pointed out that glass beads can be added to the reciprocating cylinder to simulate the chewing state of drugs in the mouth and further increase the external shear force borne by drugs.

2022-01-05

Invitation of Raytor Lecture - "The In Vitro Release of Nano Injection Studied by Flow - Through Cell Method"

Time: Friday, January 7, 2022 19：30-21：00 Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4 + 7 volume procurement, more and more pharmaceutical enterprises improve their profitability by developing innovative preparations. In this course, Raytor Instruments will take nano injection as the representative dosage form to study the dissolution of nano injection in vitro by flow-through cell method, so as to provide innovative dissolution solutions for domestic scientific researchers. The main contents of this course include: 1. Statement for experimental data. 2. Study regulatory requirements. 3. Common test methods and their advantages and disadvantages. 4. Application of flow-through cell method in the study of dissolution of nano injection in vitro 5. Next course introduction. 6. Q & A (30 minutes) Trainer Introduction Jacky Lu Technical director of Raytor Instruments, graduated from the Department of Biochemistry of Sun Yat Sen University, has worked in Takeda, Baxter, Pharmdex and other multinational enterprises for more than 10 years, and has a deep understanding of drug analysis and drug quality research.

2021-12-10

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

Nano injection can significantly improve the adverse physical and chemical properties and pharmacokinetic characteristics of drugs, improve drug stability, and increase the effective accumulation and targeted release of drugs in target tissues. It is a hot spot in drug research and development in recent years. The main types of nano injections are liposomes, nano micelles, nano suspensions, nano emulsions, etc. At present, a total of 29 nano injections have been approved by the US FDA or the European Drug Administration for the treatment and diagnosis of cancer, anemia, fungal infection, macular degeneration and other diseases. According to the technical requirements for consistency eva1uation of quality and efficacy of generic drugs for chemical drug injections (special injections), in vitro release is a key quality attribute. The in vitro release test of nano injection is usually studied by selecting appropriate methods from dialysis membrane method, flow-through cell method, Franz diffusion cell method, sample separation method, continuous flow method and other in vitro release test methods. This article will share the research results of in vitro release of a nano injection, hoping to bring inspiration and help to you. Selection of Experimental Methods The experimental methods of this in vitro release study will be selected from dialysis membrane method, flow-through cell method and Franz diffusion cell method: Dialysis membrane method: Raytor RT6 ordinary dissolution system (equipped with dialysis tube adapter) Flow-through cell method: Raytor RT7 flow-through cell dissolution system Franz diffusion cell method: Raytor RT8 transdermal diffusion system In the comparative test, the experimental parameters of the three methods are consistent as much as possible, such as using the same release medium, using the same membrane system for flow-through cell method and Franz diffusion cell method, etc. The in vitro release results showed that the release rate of the nano injection in this study was too slow under the test conditions of dialysis membrane method and Franz diffusion cell method, which did not meet the design expectation of the release time of this injection. The flow cell method is more suitable for the study of in vitro release of samples. Method Optimization Further, the experimental parameters of the flow-through cell method are optimized to obtain more repeatability and discrimination test data. The experimental results show that the optimized flow-through cell method can distinguish two batches of samples to be tested with different production processes, and the repeatability of the test data is good. Result Discussion In the research and development process of nano injection, the production process and process parameters should be comprehensively studied. For example, the particle size and its distribution have a great impact on the biological characteristics of nano injection, and its small changes may change the surface properties and other physical and chemical properties of nano preparation in blood circulation after administration, and significantly affect the stability, in vivo distribution and drug release of nanoparticles. Investigating the in vitro release behavior of nano injection by appropriate methods can effectively eva1uate the effects of different process processes and parameters on drug release, and predict its bioavailability to a certain extent. It is of great significance to product quality control, production process optimization and bioequivalence research.

2021-12-02

Application Case of Raytor Dissolution System —— Study on In Vitro Release of Sustained-Release Drug by Reciprocating Cylinder and Flow-Through Cell

Reciprocating cylinder method and flow-through cell method are commonly used in the study of drug release in vitro. They can simulate the changing physiological environment in human gastrointestinal tract by changing various dissolution media during the experiment. Therefore, some literatures will call them "biological related methods" However, the structural and design differences between the two methods determine that the test samples will face two different fluid states, which will eventually affect the experimental data. This paper will analyze the difference between the reciprocating cylinder method and the flow-through cell method by comparing the test results of the in vitro release of a sustained-release preparation. 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, both the reciprocating cylinder method and the flow-through cell method use the same sampling time point and dissolution medium. In addition, the volume of 250ml dissolution medium used in the reciprocating cylinder method can meet the sink condition. Due to the technical confidentiality agreement, the key parameters of the experimental method will be omitted in this paper. Reciprocating Cylinder（USP Apparatus 3) Dissolution system: Raytor RT3-AT reciprocating cylinder automatic sampling dissolution system Volume of dissolution medium: 250 mL Temperature: 37.0 ± 0.5 ℃ 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 ℃ A 5mm diameter ruby ball is placed at the bottom of the flow-through cell and filled with 1mm diameter glass beads. In Vitro Release Results Reciprocating Cylinder Test Result Because the reciprocating cylinder method has greater fluid shear force, the reference and self-developed samples have been basically released in 10 hours. The RSD of the final dissolution rate of the reference was 1.6%, and that of the self-developed sample was 2.3%. The repeatability of the test results was good. The final dissolution rate of the self-developed sample was slightly lower than that of the reference. Flow-Through Cell Test Result The samples tested by flow-through cell method were fully released in nearly 20 hours, which was more in line with the design expectation of 24-hour sustained release of the drug. The RSD of the final dissolution rate of the reference was 1.4%, and that of the self-developed sample was 2.8%. The repeatability of the test results was good. It can also be observed that the final dissolution rate of the self-developed sample is lower than that of the reference. Result Discussion Although both test methods can show that the final dissolution rate of the self-developed sample is lower than that of the reference, the flow-through cell method is obviously better than the reciprocating cylinder method in terms of method discrimination. The test results of flow-through cell method can more obviously show the difference between self-developed samples and reference in the whole drug release process. Thanks to the gentle constant velocity laminar flow in the flow-through cell, the drug can be released in vitro in a fluid environment closer to the gastrointestinal tract, which is easier to reflect the impact of changes in production process and prescr1ption on drug release. The reciprocating cylinder method can provide greater fluid shear force and significantly accelerate the drug release rate. While shortening the experimental time, it will sacrifice the discrimination of the method to a certain extent. Reducing the reciprocating rate can reduce the fluid shear force, but the experimental data shown that even under the condition of very low reciprocating rate (e.g. 5 DPM), the fluid shear force generated by it is still higher than that under the high flow rate of flow-through cell method. According to the characteristics of high shear force, the reciprocating cylinder method is more suitable for accelerated experiments of long-term in vitro release determination, such as implants. Through the greater fluid shear force than the paddle /basket method and the flow-through cell method, the drug release process is accelerated and the experimental time is shortened. In addition, the reciprocating cylinder method is also suitable for the study of the release of chewable tablets: glass beads are filled in the reciprocating cylinder with up and down reciprocating motion to simulate the chewed state of tablets in the mouth. The flow-through cell method and the reciprocating cylinder method have their own characteristics. We should choose the appropriate determination method according to the experimental purpose, so that the test results can meet our expectations.

2021-11-25

Invitation of Raytor Lecture - "Biological Dissolution Analysis of the Structural Mechanism of Enteric Coated Drugs"

Time: Wednesday, December 8 19：30-21：00 Location: Raytor Instruments Knowledge Store (online) Registration method: code scanning registration (company / name / contact information) Course Introduction With the promotion of 4 + 7 volume procurement, the price of traditional generic drugs has been falling all the way. Enteric coated preparation is one of the important and complex innovative preparations. Although many enterprises have conducted many be studies on the drug, there is still no way to obtain generic drugs consistent with the original research. In this course, we will share the idea of using flow-through cell method combined with biological dissolution to explain an enteric coated preparation for reference by the majority of pharmaceutical peers. The main contents of this course include: 1. Statement for experimental data. 2. Traditional R&D model. 3. Imitation model based on biological dissolution. 4. R&D dissolution → QC dissolution. 5. Next course introduction. 6. Q & A (30 minutes) Trainer Introduction Jacky Lu Technical director of Raytor Instruments, graduated from the Department of Biochemistry of Sun Yat Sen University, has worked in Takeda, Baxter, Pharmdex and other multinational enterprises for more than 10 years, and has a deep understanding of drug analysis and drug quality research.

2021-11-12

Application Case of Raytor Dissolution System —— Comparison of Discrimination between Paddle Method and Flow-Through Cell Method

As we all know, the flow-through cell method has better discrimination and biological correlation than the traditional dissolution method. This case will compare the difference of discrimination between paddle method and flow cell method under the condition of the same variable. The test sample is BCS class II oral solid tablets. Experimental Method The experimental parameters of paddle method are based on the test standards of Chinese Pharmacopoeia 2020. The flow-through cell method uses the same dissolution medium as the paddle method, the 22.6mm inner diameter of the pharmacopoeia standard flow-through cell and the pharmacopoeia standard flow rate, and the sampling time is increased by 95min and 125min on the basis of the paddle method. Paddle Method： Volume of dissolution medium: 900mL Rotational speed: 60 RPM Sampling time: 4、8、12、16、20、35、50、65 min Flow-Through Cell Method: Flow-through cell: 22.6mm inner diameter standard large cell Mode: open loop Sampling time: 4、8、12、16、20、35、50、65、95、125 min Test Result Paddle Test Results: Under the condition of paddle method, the release rate of the sample is very fast, and the dissolution rate in 8 minutes has reached more than 80%. Through the dissolution curve, we can find that the dissolution rate of the self-developed sample is slightly slower than that of the reference preparation, but the dissolution of both samples has exceeded 85% in 12 minutes. According to the judgment standard of the dissolution similarity factor F2 eva1uation method, when the dissolution of the test preparation and the reference preparation is ≥ 85% within 15 minutes, the dissolution behavior of the two preparations can be considered to be similar, and there is no need to compare F2. Flow-Through Cell Result: Thanks to the more gentle fluid environment of the flow-through cell method, the release rate of the sample slowed down significantly. Under the current test conditions of flow-through cell method, the self-developed sample obviously showed a lower dissolution level than the reference preparation. In addition, through the concentration-time curve, we can more clearly see the difference between the self-developed sample and the reference preparation: the peak concentration of the self-developed sample in the early dissolution stage is slightly higher than that of the reference preparation, but the release concentration decreases faster after reaching the peak; After the release concentration of the reference preparation reached the peak, it could maintain a higher concentration level than the self-developed sample. Result Discussion The test results show that the discrimination of flow-through cell method is better than the paddle method. This is due to the fact that the flow-through cell method can provide a fluid environment more similar to the body. Under the condition of slow laminar flow release, the test result can fully reflect the differences between different production processes. 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, the paddle method generally needs to ensure a rotational speed of at least 50rpm. In addition, reducing the rotating speed may also introduce the risk of uneven mixing. Therefore, it is not a good choice to reduce the rotational speed of paddle method in order to reduce the fluid shear force. The dissolution medium in the flow-through cell through the cell from bottom to top, which can minimize the impact of sample particle accumulation. Therefore, in general, the flow-through cell method can provide more differentiated in vitro release test data, and is more suitable for the screening of production process and drug prescr1ption in the process of preparation research and development.

2021-10-30

Mechanical Calibration Tool Kit for Paddle, Basket and Mini Vessel Method

RT200 Dissolution Apparatus Mechanical Calibration Tool Kit Raytor RT200 Dissolution Apparatus Mechanical Calibration Tool Kit is applicable to the mechanical calibration of standard ordinary dissolution apparatus by paddle method, basket method and mini vessel method. Relevant tools meet the calibration standards of Metrology Institute and the requirements of current Chinese Pharmacopoeia, US Pharmacopoeia and European Pharmacopoeia. Calibration Test Items It is equipped with a variety of high-precision measurement modules certified by measurement institutions to meet the needs of the following calibration items: shaft wobble, basket wobble, shaft verticality, vessel/shaft centering, vessel verticality, height check/basket depth, rotational speed, temperature uniformity in dissolution vessels, etc. Main Components Wireless Data Collector Digital Gradienter Tachometer Digital Thermometer Centering & Wobble Meter Depth Meter Wireless Relay & Transmitting Module