-Shenzhen Ruituo Instrument Equipment Co., Ltd

2021-09-01

12 Vessels Automatic Sampling Dissolution System

Raytor RT612-AT Automatic Sampling Dissolution System Raytor RT612-AT Automatic Sampling Dissolution System includes: Raytor RT612 Dissolution Apparatus and Raytor Dissolution Automatic Sampling Workstation. 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. Raytor Dissolution Automatic Sampling Workstation is equipped with 12 channel high-precision Raytor injection pump or plunger pump (one of the two), which also serves as paddle method, basket method and small vessel method. It can effectively provide accurate automatic sampling at each time point, reflecting the advantages of high efficiency, accuracy, stability and easy use of software. 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. Automatic Sampling Workstation More than 20 automatic sampling points can be set, and the sampling volume can reach 20ml, meeting all dissolution requirements. 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. Secondary on-line filter can be installed (e.g. 0.45 μm filter), the instrument can automatically realize two-stage on-line filtration. 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.

2021-07-30

Application Case of RT7 Flow-Through Cell Dissolution System —— In Vitro Release Test of Suspension Eye Drops

Suspension eye drops are widely used to treat various eye diseases, and the design of suspension can improve the residence time of API in front of the cornea and the bioavailability of the whole eye. Fine and relatively insoluble APIs are dispersed in the suspension eye drops, and the dosage is very small each time, which brings great difficulty to the development of in vitro release test method. However, thanks to the development and application of flow-through cell dissolution method, this technical problem can be effectively solved. In this application case, we will share the in vitro release test of suspension eye drops developed for a customer, hoping to bring help and inspiration to you. Test Method Place a 5mm diameter ruby ball at the bottom of the flow-through cell, and then fill it with 1mm diameter glass beads. Shake the sample solution and transfer it precisely for 100μL. Evenly drop the sample solution on the glass beads. An on-line filtering device is installed on the top of the flow-through cell. Start the constant flow pump and start the dissolution test. Dissolution Medium In the study of in vitro release, the physiological characteristics of drug release site in human body should be fully considered in the selection of dissolution medium. Suspension eye drops are mainly released in the eyes. When developing dissolution medium, we refer to the pH value of tears and other physiological characteristics. At the same time, an appropriate amount of surfactant is added to ensure that the sink condition are met. Test Result In this study, the in vitro release tests were performed on two self-developed samples of different suspension eye drops. The test results are as follows: Self Developed Sample 1: Self Developed Sample 2: According to the test data, we can find that the reproducibility of this method is good, the difference between the dissolution curves of three parallel tests is very small, and the RSD% of the dissolution rates of the two samples at 120min are less than 1% respectively. At the same time, this method has good discrimination and can distinguish the difference of dissolution behavior between different samples.

2021-06-23

Application Case of RT7 Flow-Through Cell Dissolution System —— Dissolution Study of Soft Capsule

In the process of soft capsule R&D and quality control, the development of dissolution method has always been a troublesome difficulty. This is because: when the soft capsule is dissolved, an oil layer will be formed above the dissolution medium, and the oil droplets produced in the dissolution process may also be suspended in the dissolution medium, which makes it difficult for the traditional dissolution method to effectively determine its dissolution. Therefore, in this application case, we will share the dissolution research of a soft capsule product for a customer, hoping to bring inspiration and help to you. Selection of Flow-Through Cell In addition to the two flow-through cells with inner diameters of 22.6mm and 12mm contained in the Pharmacopoeia, there is also a flow-through cell suitable for soft capsule dissolution test in the European Pharmacopoeia (as shown in the figure below). When in use, first put the sample into chamber A of the flow-through cell, and then install the online filter component on the top of the cell. During the test, the dissolution medium will enter from the bottom of chamber A and fill chamber A; Then, the dissolution medium flows from chamber A into chamber B and fills it; Finally, the dissolved medium flows upward through the pipeline at the bottom of chamber B, passes through the line filter assembly, and completes the collection of sample solution through the automatic sampling system. Method Optimization The lipid phase of the soft capsule will prevent its main drug from entering the dissolution medium. In addition, some drugs with poor water solubility may not meet the sink conditions. This may result in slow dissolution or incomplete dissolution. Adding surfactant to dissolution medium is an effective means to solve the above problems. This study comprehensively investigated the solubility of the main drug components at different concentrations of different surfactants, so that the test method has sufficient discrimination on the premise of ensuring the complete dissolution of the sample. When selecting the temperature of dissolution medium, the melting temperature of soft capsule shell should be considered. More accurate temperature control and smaller temperature difference between flow-through cells can ensure more stable and reliable test results. Research Results In this study, dissolution tests were carried out on the reference and self-developed samples of three different production processes. The test results are shown in the figure below: The dissolution similarity factors (f2) of sample 1 and sample 3 and reference were 28 and 52 respectively. For sample 2, the capsule shell did not disintegrate during the dissolution process, and its contents were not released from the capsule shell until the end of the experiment, resulting in extremely low dissolution results. Conclusion From the above results, we can know that the capsule shell process of soft capsule is one of the keys to control its release behavior. The dissolution release of soft capsule can be effectively determined by flow-through cell method. Furthermore, the dissolution results with good discrimination can scientifically guide the optimization and improvement of the production process.

2021-06-21

应用与行业

2021-06-21

Mr. Zhang

"The engineers of Agilent Chengdu instrument service center can meet the needs of customers, solve the instrument faults quickly with skilled and professional technology, conduct a comprehensive inspection of the instrument and eliminate the potential faults of the instrument at the same time, ensure the normal operation of the instrument and the smooth progress of the project.

2021-05-13

Application Case of RT7 Flow-Through Cell Dissolution System —— Drug Dissolution Study under Physiological Conditions

After oral administration of solid preparations, the absorption of drugs depends on the dissolution or release of drugs from the preparations, the dissolution of drugs under physiological conditions and the penetration of drugs in the gastrointestinal tract. Therefore, if the in vitro dissolution test can simulate the physiological environment of human gastrointestinal tract, the dissolution method will have better discrimination and better predict the drug behavior in vivo. In this application case, we will share the dissolution research of a BCS class II product under physiological conditions for a customer, hoping to bring inspiration and help to you. Research Method Dissolution Apparatus：Raytor RT7 Flow-Through Cell Dissolution System Flow-Through Cell：22.6mm inner diameter pharmacopoeia standard large cell Dissolution Medium：a variety of dissolution media simulating the pH environment of human pre meal gastrointestinal tract Flow Rate： technical confidentiality Mode：open loop Filtration System：Raytor patented on-line filtering device Dissolution Study under Physiological Conditions Place the customer's self-developed sample and the reference in the flow-through cell respectively, start the dissolution test according to the proposed research method, collect the sample solution at each sampling time point in the open-loop mode, detect the API concentration by HPLC. Concentration-Time Curve According to the test results, we can find that: (1) The self-developed sample and the reference basically did not dissolve in the simulated stomach stage. (2) After entering the simulated small intestine stage, the peak concentration of the self-developed sample was higher than that of the reference, and the time for the self-developed sample to reach the peak concentration was slightly earlier than that of the reference. Based on the experimental results, it is reasonable to infer that there are differences in the release behavior of self-developed samples and reference after gastric emptying into the small intestine. Further, calculate the cumulative dissolution rate at each sampling time point. Dissolution Rate-Time Curve Select the dissolution data of simulated small intestine stage, and calculate the similarity factor (f2) = 41.5, indicating that under the current experimental conditions, the in vitro release behavior of self-developed samples and reference in simulated pre meal small intestine environment is not similar. Development of QC Dissolution Method In order to meet the effective monitoring of product quality in QC stage, according to the dissolution research results under the above physiological conditions, we simplified and optimized the dissolution parameters and dissolution medium formula of the flow-through cell method, so as to shorten the test time and simplify the dissolution medium preparation and dissolution test steps. The simplified and optimized flow-through cell dissolution method is used to detect the self-developed sample and the reference, and the dissolution rate-time curve of the two is compared: On the premise that there is no more than one time point when the dissolution exceeds 85%, the similarity factor (f2) = 37.8 is calculated. It is proved that this method still has excellent discrimination. In addition, the repeatability test results showed that the relative standard deviation (RSD) of the final dissolution rate of the self-developed sample and the reference were both less than 2%. It is proved that the method has good repeatability. The above results show that the flow-through cell method has the potential to be developed as a QC dissolution method, especially in terms of discrimination, it has great advantages over the traditional dissolution method. Conclusion The flow-through cell dissolution apparatus can freely switch different kinds of dissolution media during the dissolution test, and the hydrodynamics is closer to the human gastrointestinal environment. Thanks to these design advantages, the flow-through cell dissolution apparatus can better simulate the physiological environment of human gastrointestinal tract, the test results have better discrimination, and can better predict the behavior of drugs in vivo.

2021-04-20

Application Case of RT7 Flow-Through Cell Dissolution System —— In Vitro Dissolution Study of Rapid Release Tablet

Raytor Instruments Application Technology Department accepted the entrustment of a customer to study the in vitro release of a rapid release tablet in the development stage. Due to the fast release rate of the product, the discriminative data cannot be obtained by using the traditional dissolution method, so it is decided to use Raytor RT7 flow-through cell dissolution system (the sixth method for dissolution determination in Chinese Pharmacopoeia, 2020 Edition) for research. Experimental Parameters Dissolution Apparatus: Raytor RT7 flow-through cell dissolution system Dissolution Medium: technical confidentiality Temperature: 37 ℃± 0.5 ℃ Mode: open loop Flow-Through Cell: pharmacopoeia standard large cell (22.6mm inner diameter) Flow Rate: technical confidentiality Sampling time: the first 5 minutes: once every 15 seconds; 5-20 minutes: once every 30 seconds Filtering Device: Raytor patented online filtering device Research Process A ruby ball with a diameter of 5mm is placed at the bottom of the cone of the cell, and the cone part is filled with glass beads with a diameter of 1mm, so that the dissolution medium entering the flow cell becomes laminar flow. Place the sample to be tested and the reference sample on the drug stent, and install the Raytor patent on-line filtration device. After the flow-through cell was installed, the open-loop dissolution experiment was started. The system will automatically send the dissolution medium into the flow-through cell at a constant flow rate. The automatic sampling workstation automatically collects the sample solution according to the preset sampling time. Thanks to the advanced design of Raytor RT7 flow-through cell dissolution system, the sampling time interval can be compressed to 15 seconds, so that small changes in the rapid release process of samples can be captured in the study. Use the HPLC system to analyze the concentration of the collected sample solution and calculate the cumulative dissolution rate. Results and Discussion Concentration-Time Curve Draw the concentration-time curve according to the concentration of the sample solution at each sampling time point. The test results can effectively show the difference between reference and samples. The difference between the sample and the reference preparation can be effectively compared by the peak concentration (Cmax), peak arrival time (Tmax) and the time when the peak concentration decreases by half (T1 / 2) of the in vitro release curve of the sample and the reference. Dissolution Rate-Time Curve According to the concentration of sample solution at each sampling time point, calculate the cumulative dissolution rate at each sampling time point, and draw the dissolution rate-time curve. When the dissolution rate of the reference is 30%, 50%, 80% and the final sampling time point, the dissolution rate results of the reference and the sample are compared. It is suggested that the difference of dissolution rate should be within 10%. Conclusion The flow-through cell method has better discrimination and in vivo and in vitro correlation than the traditional dissolution method, and the test method and sampling time are more flexible. It has always been a better way in the research and development. The results of this study effectively distinguish the differences between the reference and the samples, and provide effective technical and data support for its prescr1ption and process optimization.

2021-04-10

Drug R&D / Analysis / Dissolution Technology Conference

From April 8 to 9, 2021, Raytor Instruments participated in the Drug R&D / Analysis / Dissolution Technology Conference held in Nanjing. At the conference, Raytor Instruments showed its main dissolution products and had in-depth exchanges with experts and teachers. Among them, Raytor RT7 flow-through cell dissolution system has attracted the attention of various experts and teachers because it can effectively study the in vitro release of various innovative preparations (such as microspheres, liposomes, soft capsules, microemulsion, etc.). Raytor Instruments Booth Raytor RT7 Flow-Through Cell Dissolution System Raytor Instruments shares the drug dissolution scheme in vitro with flow-through cell method as the core technology The dissolution system of flow-through cell method attracted the attention of participating teachers

2021-03-01

Application Case of RT7 Flow-Through Cell Dissolution System —— Dissolution Study of API

No matter in the drug research and development stage or in the quality control stage, the analysis of key factors such as crystal form, particle size distribution and surface area of API is the top priority. The dissolution test of API can directly reflect the impact of the changes of these key factors on its bioavailability. Among the many dissolution test methods of API, the flow-through cell method has always been considered as the best choice. The European Pharmacopoeia contains the method for determining the dissolution of API by the flow-through cell system: 2.9.43 Apparent Dissolution. This article will share some cases and technical experience of using Raytor RT7 flow-through cell dissolution system to carry out API dissolution research for customers, hoping to bring you help and inspiration. Research Method In the dissolution study of API, the flow-through cell device specially used in chapter 2.9.43 of European Pharmacopoeia: powder cell is used. A ruby ball with a diameter of 5mm is placed at the bottom of the cone of the powder cell, and the cone part is filled with glass beads with a diameter of 1mm, so that the dissolution medium will become laminar flow after entering the cell . After installing the screen and filter membrane components at the bottom, weigh an appropriate amount of API samples and place them in the powder cell, then place a special screen insertion component above the samples, and finally install the on-line filter device at the top of the powder pool. After the dissolution experiment, the system will automatically send the dissolution medium into the powder cell at a constant flow rate. The automatic sampling workstation automatically collects the sample solution according to the preset sampling time. Dissolution Study of Rapid Release API The sample for this dissolution study is the API of a rapid release preparation entrusted by a customer. Due to the rapid release rate of its API, it is difficult to accurately determine the dissolution curve and the change of release rate by general dissolution methods. The RT7 flow-through cell dissolution system, combined with the fast continuous sampling mode with 15 second interval, can complete the customer demand measurement with high precision. The flow-through cell method provides a powerful analytical means for screening different types of APIs in the R&D stage or monitoring the quality of different batches of APIs in the quality control stage. Concentration-Time Curve Dissolution Rate-Time Curve Dissolution Study of Poorly Soluble API The sample for this dissolution study is an poorly soluble API entrusted by a customer. In order to make the dissolution environment of the samples reach the sink condition, the general dissolution determination methods need to use a high concentration of surfactant, which leads to the serious lack of discrimination of this method. In order to achieve the purpose of effective discrimination, while using the flow-through cell method in the research process, we also optimized the key parameters of the method, dissolution medium and on-line filtration system. The following is the dissolution curve of API with different process parameters within 4 hours in a specific dissolution medium: The flow-through cell method can effectively distinguish the effects of different process parameters of API on dissolution. According to the results, we can reasonably speculate that the bioavailability of API 1 will be significantly higher than API 2. Conclusion The flow-through cell dissolution system is suitable for the dissolution determination of APIs of various properties and forms, and has the advantages of high accuracy, high precision and high discrimination.

2021-01-23

Drug CMC International Summit Forum

From January 20 to 21, 2021, Raytor Instruments participated in the Drug CMC International Summit Forum in the beautiful Yangcheng - Guangzhou Sunshine Hotel. At the forum, the colleagues of Raytor Technology Department shared our opinions on the prediction of drug bioavailability and dissolution test of complex drugs concerned by the colleagues of pharmaceutical enterprises. The solutions we proposed were understood and recognized by the teachers of participating pharmaceutical enterprises and R&D enterprises. After the meeting, the participating experts and teachers paid great attention to the solution of drug bioavailability prediction by Raytor Instruments with flow-through cell dissolution. The present teachers and experts also recognized the physiological prediction ability of drugs and the testing ability of complex preparations displayed by the flow-through cell dissolution apparatus. In addition to the flow-through cell dissolution apparatus, the RT612-AT automatic sampling dissolution system of Raytor Instruments with Raytor "cloud" interconnection technology also received great attention from the participating teachers. Raytor Instruments Booth Raytor Instruments shares the drug dissolution scheme in vitro with the flow-through cell method as the prediction core technology Three different types of dissolution tests: in vitro dissolution behavior prediction and drug pre development are carried out with the flow-through cell scheme, supplemented by the automatic blood drug extraction workstation for blood sample preparation, and the two data are integrated to produce the effect of IVIVC. Raytor RT7 flow-through cell dissolution system - received great attention from the teachers attending the meeting. Automatic blood drug analysis workstation, enabling blood drug extraction and testing. Raytor RT911 automatic dissolution workstation can help customers automatically perform dissolution experiments in multiple batches and reduce enterprise costs. Many teachers came to the Raytor booth to exchange technology on the scheme of in vitro physiological dissolution prediction in the flow-through cell .

2020-09-09

Seminar on High Quality Development of Chinese Pharmaceutical

From August 28 to 29, 2020, the Seminar on High Quality Development of Chinese Pharmaceutical preparations was grandly held in Qingdao, Shandong Province. As a special partner of this seminar, Raytor Instruments appeared at the conference site with a full range of dissolution products, including RT7 flow-through cell dissolution system, RT3 reciprocating cylinder dissolution system and RT612 / RT600 series automatic sampling dissolution system. As the first commercialized flow-through cell dissolution apparatus in China, Raytor RT7 flow-through cell dissolution system attracted great attention of teachers and guests as soon as it appeared at the meeting. On site Raytor Instruments technicians and expert teachers share the development experience of flow-through cell dissolution method, and explore the application and advantages of flow-through cell method in preparation research and development.

2020-02-20

Raytor Instruments Obtained the National High-Tech Enterprise Certification

According to GXHZ [2020] No. 47: Reply on the filing of the second batch of high-tech enterprises in Shenzhen in 2019, Raytor Instruments Co., Ltd. was filed as a national high-tech enterprise and obtained the "high-tech enterprise certificate" (Certificate No.: GR201944203546). The high-tech enterprise certification this time is the full affirmation of the innovative technology ability of Raytor Instruments by the Ministry of Science and Technology of the People's Republic of China. Raytor Instruments will make persistent efforts to continuously improve its innovation ability and technical level, and provide users with more advanced products and professional services.