Practical Considerations in Developing a Quality Control (In Vitro Release) Procedure for Topical Drug Products

2020 ◽

pp. 12-15

Keyword(s):

Quality Control ◽

Quality Evaluation ◽

In Vitro Release ◽

Control Parameters ◽

Dissolution Tests ◽

Quality Control Parameters ◽

Retail Outlets ◽

Release Study ◽

Vitro Release

The study evaluated different quality control parameters of five brands of Cefuroxime 250mg tablets which are already marketed in Bangladesh. Five brands of the drug sourced from different retail outlets to assess the quality assessment and comparison of the tablets using the in-vitro release study. The brands were subjected to various official tests including uniformity of weight, thickness test, dissolution tests, and cumulative % of drug release and friability test. This research further focuses on the requirement of manufacturers to construct quality into their products during manufacture and also sustain the built-in quality from batch to batch in line with the principles of cGMP.

Download Full-text

A A COMPARATIVE STUDY OF QUALITY CONTROL TESTING ON CANDESARTAN CILEXETIL CONVENTIONAL TABLETS IN IRAQ

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2020v12i2.36220 ◽

2020 ◽

pp. 103-108

Author(s):

KARRAR TALIB KHUDHAIR ALBO HAMRAH ◽

ABULFADHEL JABER NEAMAH AL-SHAIBANI ◽

SARMAD SABAH AL-EDRESI ◽

KARRAR MOHAMMED HASAN AL-GBURI

Keyword(s):

Quality Control ◽

Candesartan Cilexetil ◽

In Vitro Release ◽

Simulated Gastric Fluid ◽

Control Analysis ◽

Disintegration Time ◽

Drug Content ◽

Release Study ◽

Vitro Release

Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies. Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia. Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min. Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia.

Download Full-text

Fig. 12 Scanning electron micrograph of D.L-PLA nanoparticles loaded with CGP 57813. (Ref. 51.) scanning force microscopy (also called atomic force microscopy), enable the visualiza-tion of nanoparticles at atmospheric pressure without gold coating [12,64]. Neverthe-less, the resolution obtained with these new tools is still lower than that with SEM. For size determination, transmission electron microscopy is not as widely used as PCS and SEM, but it is still a powerful method for determining the morphology of particles. With this technique, Fessi et al. [42] estimated the wall thickness of PLA nanocapsules. Krause et al. [18] described the highly porous structure of PLA nano-spheres prepared by the emulsion-evaporation procedure. VIII. IN VITRO RELEASE STUDIES In vitro release studies should in principle be useful for quality control as well as for the prediction of in vivo kinetics. Unfortunately, due to the very small size of the par-ticles, the release rate observed in vivo can differ greatly from the release obtained in a buffer solution. However, in vitro release studies remain very useful for quality control as well as for evaluation of the influence of process parameters on the release rate of active compounds. In vitro drug release from microdispersed systems has been exten-sively reviewed by Washington [65]. Depending on the type of polyester, drug release from nanoparticles can take place through several processes, of which the following appear to be the most important: (1) The drug may diffuse out of the carrier through the solid matrix; to allow complete release from the carriers, (the concentration of drug in the release medium should re-main infinitely low, which condition is known as sink condition); (2) The solvent may penetrate the nanoparticles and dissolve the drug, which then diffuses out into the re-lease medium. Depending on the physico-chemical characteristics of the particles, wa-ter can enter the particles through narrow pores or by hydration. Once the drug is dis-solved, the drug diffuses out of the particles. Here again, since diffusion is driving the

Pharmaceutical Dosage Forms ◽

10.1201/9781420000955-25 ◽

1998 ◽

pp. 204-216

Keyword(s):

Quality Control ◽

Drug Release ◽

Release Rate ◽

In Vitro Release ◽

Scanning Force Microscopy ◽

Force Microscopy ◽

Release Studies ◽

Vitro Release

Download Full-text

Role of in vitro release models in formulation development and quality control of parenteral depots

Expert Opinion on Drug Delivery ◽

10.1517/17425240903307431 ◽

2009 ◽

Vol 6 (12) ◽

pp. 1283-1295 ◽

Cited By ~ 55

Author(s):

Claus Larsen ◽

Susan Weng Larsen ◽

Henrik Jensen ◽

Anan Yaghmur ◽

Jesper Østergaard

Keyword(s):

Quality Control ◽

In Vitro Release ◽

Formulation Development ◽

Vitro Release

Download Full-text

QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2022v14i1.43331 ◽

2022 ◽

pp. 221-225

Author(s):

MAZIN THAMIR ABDUL-HASAN ◽

ABULFADHEL JABER NEAMAH Al-SHAIBANI ◽

ALI N. WANNAS ◽

KARRAR MOHAMMED HASAN AL-GBURI

Keyword(s):

Quality Control ◽

In Vitro Release ◽

Gastric Fluid ◽

Disintegration Time ◽

Drug Content ◽

Clopidogrel Bisulfate ◽

Weight Variation ◽

Release Study ◽

Vitro Release

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.

Download Full-text

In vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug products in Brazil

Brazilian Journal of Pharmaceutical Sciences ◽

10.1590/s1984-82502013000200003 ◽

2013 ◽

Vol 49 (2) ◽

pp. 211-219 ◽

Cited By ~ 7

Author(s):

Karin Goebel ◽

Mayumi Eliza Otsuka Sato ◽

Dayse Fernanda de Souza ◽

Fábio Seigi Murakami ◽

Itamar Francisco Andreazza

Keyword(s):

Drug Release ◽

Generic Drug ◽

Drug Product ◽

In Vitro Release ◽

Performance Testing ◽

Vertical Diffusion ◽

Reference Drug ◽

Drug Products ◽

Vitro Release

In order for the pharmacological action of a topical dermal drug product to occur, the drug must first be released from the vehicle to be available to penetrate the skin layers and reach the site of action. Drug release is mainly dependent on the characteristics of the formulation. Currently, to register a generic or a similar drug product in Brazil performance testing of topical drug products for local action is not required. In this context, this aim of this study was to evaluate the in vitro release of commercial diclofenac diethylamine gel products available on the Brazilian pharmaceutical market, using the vertical diffusion cell method. Factors which may influence the test, such as the type of membrane used, and the effect of the formulation characteristics on the diffusion rate were evaluated. Brazilian legislation currently allows generic drug products to contain excipients other than the reference drug, which may affect the drug release from the vehicle. Only one of the four generic drug products tested could be considered equivalent to the reference Cataflam Emulgel®. The cellulose acetate and polyethersulfone membranes tested were found to be interchangeable in the in vitro release studies carried out on this product.

Download Full-text

COMPARISON OF THE USP APPARATUS 2 AND 4 FOR TESTING THE IN VITRO RELEASE PERFORMANCE OF IBUPROFEN GENERIC SUSPENSIONS

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017v9i4.19926 ◽

2017 ◽

Vol 9 (4) ◽

pp. 90 ◽

Cited By ~ 1

Author(s):

Jose Raul Medina ◽

Mariel Cortes ◽

Erik Romo

Keyword(s):

In Vitro Release ◽

Generic Product ◽

Dissolution Profile ◽

Drug Products ◽

Flow Through ◽

Usp Apparatus 4 ◽

Usp Apparatus ◽

Usp Apparatus 2 ◽

Vitro Release

Objective: The aim of this study was the comparison of the in vitro release performance of ibuprofen generic suspensions and reference, based on the hydrodynamic environment generated by the flow-through cell method (USP Apparatus 4). Results were compared with those obtained by the use of the USP Apparatus 2.Methods: The Advil® suspension (2 g/100 ml) and two generic formulations with the same dose were tested. Dissolution studies were carried out using a USP Apparatus 4 Sotax CE6 with 22.6 mm cells, laminar flow at 16 ml/min, and pH 7.2 phosphate buffer at 37.0±0.5 °C as dissolution medium. Ibuprofen was quantified spectrophotometrically at 222 nm. The in vitro release of the three drug products were studied using the USP Apparatus 2. The dissolution profiles of generic products were compared with the reference by model-independent, model-dependent, and analysis of variance (ANOVA)-based comparisons.Results: The dissolution profile of the generic product A was similar to the dissolution profile of reference, only with the use of the USP Apparatus 4. The f2 similarity factor was>50 and no significant differences were found with dissolution efficiency data (*P>0.05). Similar results were found with the comparison of t50% and t63.2% values. Similar dissolution profiles between generic product A and reference were also found with ANOVA-based comparisons.Conclusion: The flow-through cell method was adequate for study the in vitro release of ibuprofen suspensions. It is necessary to evaluate the in vivoperformance of the drug products used in order to estimate the predictability of the proposed methodology.

Download Full-text