Dissolution and Dissolution Test Apparatus: A Review

2021 ◽  
Vol 11 (3) ◽  
pp. 229-236
Author(s):  
Priyanka M. Salve ◽  
Shital V. Sonawane ◽  
Mayuri B. Patil ◽  
Rajendra K. Surawase
Keyword(s):  
Dosage Form ◽  
Immediate Release ◽  
Drug Dissolution ◽  
Dissolution Testing ◽  
Dissolution Test ◽  
Drug Bioavailability ◽  
Drug Degradation ◽  
Chewing Gums ◽  
Dissolution Apparatus

Dissolution is an official test. These used by pharmacopeias for evaluating drug release of solid and semisolid dosages forms. The application of the dissolution testing ensures consistent product quality and to predict in vivo drug bioavailability. The dissolution test, in its simplest form, placing the formulation in a dissolution apparatus containing suitable dissolution medium, allowing it to dissolved specified period of time and then using appropriate rational method to determine the amount of drug. Dissolution test are probative and analysis like drug degradation profile, shelf-life studies, stability, physical and mechanical testing of dosage forms. The present review outlines findings on various dissolution apparatus, various methods and their modification. Dissolution testing the of various dosage form like Delayed release dosage form, Immediate release dosage form, Extended-release dosage form, Powders, Chewable tablets, Transdermal delivery system, Buccal tablets, Soft gelatin capsule, Chewing gums, Suppositories, Aerosols and others semisolids. This article goal of the description of the all-official dissolution testing apparatus.

scholarly journals Crushed Tablets: Does the Administration of Food Vehicles and Thickened Fluids to Aid Medication Swallowing Alter Drug Release?

2014 ◽  
Vol 17 (2) ◽  
pp. 207 ◽  
Author(s):  
Yady Juliana Manrique-Torres ◽  
Danielle J Lee ◽  
Faiza Islam ◽  
Lisa M Nissen ◽  
Julie A.Y. Cichero ◽  
...  
Keyword(s):  
Drug Release ◽  
Orange Juice ◽  
Immediate Release ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Simulated Gastric Fluid ◽  
Drug Bioavailability ◽  
Thickening Agents

Purpose. To evaluate the influence of co-administered vehicles on in vitro dissolution in simulated gastric fluid of crushed immediate release tablets as an indicator for potential drug bioavailability compromise. Methods. Release and dissolution of crushed amlodipine, atenolol, carbamazepine and warfarin tablets were tested with six foods and drinks that are frequently used in the clinical setting as mixers for crushed medications (water, orange juice, honey, yoghurt, strawberry jam and water thickened with Easythick powder) in comparison to whole tablets. Five commercial thickening agents (Easythick Advanced, Janbak F, Karicare, Nutilis, Viscaid) at three thickness levels were tested for their effect on the dissolution of crushed atenolol tablets. Results. Atenolol dissolution was unaffected by mixing crushed tablets with thin fluids or food mixers in comparison to whole tablets or crushed tablets in water, but amlodipine was delayed by mixing with jam. Mixing crushed warfarin and carbamazepine tablets with honey, jam or yoghurt caused them to resemble the slow dissolution of whole tablets rather than the faster dissolution of crushed tablets in water or orange juice. Crushing and mixing any of the four medications with thickened water caused a significant delay in dissolution. When tested with atenolol, all types of thickening agents at the greatest thickness significantly restricted dissolution, and products that are primarily based on xanthan gum also delayed dissolution at the intermediate thickness level. Conclusions. Dissolution testing, while simplistic, is a widely used and accepted method for comparing drug release from different formulations as an indicator for in vivo bioavailability. Thickened fluids have the potential to retard drug dissolution when used at the thickest levels. These findings highlight potential clinical implications of the addition of these agents to medications for the purpose of dose delivery and indicate that further investigation of thickened fluids and their potential to influence therapeutic outcomes is warranted. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals REVITALISASI PENGGUNAAN OBAT GENERIK

2012 ◽  
Vol 1 (2) ◽  
Author(s):  
Nanang Yunarto
Keyword(s):  
Generic Drugs ◽  
Health Care Facilities ◽  
Drug Dissolution ◽  
Dissolution Test ◽  
Test Results ◽  
Drug Bioavailability ◽  
Branded Drugs ◽  
The Government

The government through the Ministry of Health is very serious about revitalizing the use of generic drugs by issuing a policy that stipulated in the Regulation of the Minister of Health No. HK. 02.02/Menkes/068/1/2010 about duty to use generic drugs in government health care facilities. To maximize the use of generic drugs, it is very important to improve understanding and trust of society that generic drugs have the quality, safety and effectiveness are similar to branded drugs. Besides that, there is a lot of research and the study of generic drugs will increase the knowledge, so that health professionals, especially doctors do not hesitate to prescribe generic drugs. Quality used as a basis of reference to establish the truth of the eficacy and safety. For availability of certain products can be demonstrated in vitro. Studies of drug dissolution gave the same indication with drug bioavailability. Ideally, in vitro drug dissolution correlates bioavailability in vivo. From the research results of dissolution test generic drugs Amoxiciline 500 mg tablets, Isosorbit Dinitrat 5 mg tablets and Omeprazole capsules compared to branded drugs show no less generic drugs than branded drugs, dissolution test results even better generic drugs

scholarly journals Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Zhongmei Chi ◽  
Irfan Azhar ◽  
Habib Khan ◽  
Li Yang ◽  
Yunxiang Feng
Keyword(s):  
High Speed ◽  
Sequential Analysis ◽  
Immediate Release ◽  
Drug Dissolution ◽  
High Temporal Resolution ◽  
Dissolution Profile ◽  
Dissolution Testing ◽  
Combination Drug ◽  
Efficient Separation ◽  
High Efficient

AbstractDissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is a challenging task to perform both high-efficient separation and high-temporal detection to achieve accurate dissolution profile of each active ingredient dissolved from a drug tablet. In our study, we report a novel non-manual-operation method for performing the automatic dissolution testing of drug tablets, by combining a program-controlled sequential analysis and high-speed capillary electrophoresis for efficient separation of active ingredients. The feasibility of the method for dissolution testing of real drug tablets as well as the performance of the proposed system has been demonstrated. The accuracy of drug dissolution testing is ensured by the excellent repeatability of the sequential analysis, as well as the similarity of the evaluation of dissolution testing. Our study show that the proposed method is capable to achieve simultaneous dissolution testing of multiple ingredients, and the matrix interferences can be avoided. Therefore it is of potential valuable applications in various fields of pharmaceutical research and drug regulation.

scholarly journals Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen

2021 ◽  
pp. 121415
Author(s):  
I Cámara-Martinez ◽  
J.A. Blechar ◽  
A. Ruiz-Picazo ◽  
A. Garcia-Arieta ◽  
C. Calandria ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dissolution Testing

In-Vitro Functionality of Clozapine Biphasic Release Minitablet Using Advanced Statistical Tools

2021 ◽  
Vol 11 ◽  
Author(s):  
Hardik Rana ◽  
Rushikesh Chaudhari ◽  
Vaishali Thakkar ◽  
Tejal Gandhi
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Ethyl Cellulose ◽  
Dosage Form ◽  
Immediate Release ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Precipitation Inhibitor

Background: The better control of the drug release with immediate effect is the major concern to achieve better therapeutic action and patient compliance. The failure of the solid dispersion complex during storage as well as in-vivo is another concern for the oral solid dosage form. Objective: The prime objective of the present study was to optimize the biphasic minitablet incorporating quality by design approach using the combination of waxy erodible and water-impermeable excipients. Exploration of Soluplus as a precipitation inhibitor and Dexolve as a solubility enhancer in oral solid dosage form was the secondary objective. Methods: The drug-Excipient compatibility study was assessed by FTIR. Clozapine was chosen as a model drug that has poor aqueous solubility. The complex was formulated using B-cyclodextrin or HP B-CD or Dexolve by kneading method. The screening of solubility enhancers and their amount were performed based on phase solubility study. The precipitation inhibitor was screened as per the parachute effect study. Immediate release minitablets were formulated using a direct compression method using different disintegrating agents. The IR minitablets were evaluated for different evaluation parameters. The sustained release minitablets was formulated by hot-melt granulation technique incorporating the Precirol ATO 5 as a waxy excipient and ethyl cellulose as water impermeable excipient. The SR minitablet was optimized using a central composite design. The amount of Precirol ATO 5 and ethyl cellulose were chosen as independent variables and % drug release at 1, 6, and 10 h was selected as responses. The designed batches were evaluated for different pre and post compressional parameters. The IR and SR minitablets were filled in a capsule as per dose requirement and evaluated for in-vitro drug release. The in-vivo plasma concentration was predicted using the Back calculation of the Wagner – Nelson approach. Results: Drug – Excipient study revealed that no significant interaction was observed. Dexolve was screened as a solubility enhancer for the improvement of the solubility of clozapine. The Soluplus was chosen as a precipitation inhibitor from the parachute effect study. The immediate-release tablet was formulated using Prosolv EASYtab SP yield less disintegration time with better flowability. The sustained release mini-tablet was formulated using Precirol ATO 5 and ethyl cellulose. Two-dimensional and three-dimensional plots were revealed the significant effect of the amount of Precirol ATO 5 and ethyl cellulose. The overlay plot locates the optimized region. The in-vitro drug release study revealed the desired drug release of the final combined formulation. The in-vivo plasma concentration-time confirms the drug release up to 12h. Conclusion: The biphasic mini-tablets were formulated successfully for better control of drug release leads to high patient compliance. The use of soluplus as a precipitation inhibitor is explored in the oral solid dosage form for a poorly aqueous drug. Prosolv EASYtab SP was incorporated in the formulation as super disintegrant. The amount of Precirol ATO 5 and ethyl cellulose had a significant effect on drug release in sustained-release minitablet. The approach can be useful in the industry.

scholarly journals Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance Part 2: Dissolution of Montelukast Sodium and Mesalazine Formulations

2020 ◽  
Vol 21 (7) ◽  
Author(s):  
J. Martir ◽  
T. Flanagan ◽  
J. Mann ◽  
Nikoletta Fotaki
Keyword(s):  
Drug Formulation ◽  
Drug Dissolution ◽  
Simulated Gastric Fluid ◽  
Dissolution Testing ◽  
Drug Bioavailability ◽  
Age Appropriate ◽  
Direct Administration ◽  
The Impact ◽  
Paediatric Formulation

Abstract Paediatric medicines are not always age-appropriate, causing problems with dosing, acceptability and adherence. The use of food and drinks as vehicles for medicine co-administration is common practice, yet the impact on drug bioavailability, safety and efficacy remains unaddressed. The aim of this study was to use in vitro dissolution testing, under infant simulating conditions, to evaluate the effect of co-administration with vehicles on the dissolution performance of two poorly soluble paediatric drugs. Dissolution studies of mesalazine and montelukast formulations were conducted with mini-paddle apparatus on a two-stage approach: simulated gastric fluid followed by addition of simulated intestinal fluid. The testing scenarios were designed to reflect daily administration practices: direct administration of formulation; formulation co-administered with food and drinks, both immediately after mixing and 4 h after mixing. Drug dissolution was significantly affected by medicine co-administration with vehicles, compared to the direct administration of formulation. Furthermore, differences were observed on drug dissolution when the formulations were mixed with different vehicles of the same subtype. The time between preparation and testing of the drug-vehicle mixture also impacted dissolution behaviour. Drug dissolution was shown to be significantly affected by the physicochemical properties and composition of the vehicles, drug solubility in each vehicle and drug/formulation characteristics. Ultimately, in this study, we show the potential of age-appropriate in vitro dissolution testing as a useful biopharmaceutical tool for estimating drug dissolution in conditions relevant to the paediatric population. The setup developed has potential to evaluate the impact of medicine co-administration with vehicles on paediatric formulation performance.

Microfluidic Measurements of Drug Dissolution Using a Quartz Crystal Microbalance

2016 ◽  
Author(s):  
Shelly Gulati ◽  
Janpierre A. Bonoan ◽  
Kylee V. Schesser ◽  
Joshua F. Arucan ◽  
Xiaoling Li
Keyword(s):  
Benzoic Acid ◽  
Quartz Crystal Microbalance ◽  
Quartz Crystal ◽  
Rapid Test ◽  
The Body ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Dissolution Testing ◽  
Testing Method

This work describes a microfluidic drug dissolution testing method that was developed using a commercial quartz crystal microbalance (QCM) resonator combined with an axial microfluidic flow cell. Dissolution testing is used to obtain temporal dissolution profiles of drugs, which provide information on the bioavailability or the drug’s ability to be completely dissolved and then absorbed and utilized by the body. Feasibility of the QCM dissolution testing method was demonstrated using a sample drug system of thin films of benzoic acid dissolved in water, capturing the drug dissolution profile under different microflow conditions. Our analysis method uses the responses of resonance frequency and resistance of the quartz crystal during dissolution testing to determine the characteristic profiles of benzoic acid dissolved over a range of microflows (10–1000 μL/min). The initial dissolution rates were obtained from the characteristic profiles and found to increase with higher flow rates. This aligns with the expected trend of increased dissolution with higher hydrodynamic forces. The QCM-based microfluidic drug dissolution testing method has advantages over conventional dissolution test methods, including reduced sample sizes, rapid test durations, low resource requirements, and flow conditions that more closely model in vivo conditions.

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