In-process and Finished Products Quality Control Tests for Pharmaceutical Capsules According to Pharmacopoeias

Uddin, Md. Sahab; Mamun, Abdullah Al; Rashid, Mamunur; Asaduzzaman, Md.

doi:10.9734/bjpr/2016/22044

Cited by 33 publications

(63 citation statements)

References 3 publications

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“…The difference in the two weights was used to calculate weight variation by using the following formula [19, 29, 30]:where, I w = Individual weight of the tablet and A w = Average weight of the tablet.…”

Section: Methodsmentioning

confidence: 99%

In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh

et al. 2017

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BackgroundCiprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. The study was carried out to examine the in vitro quality control tests for ten leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Bangladesh by Directorate General of Drug Administration. The quality control parameters of ten different brands of ciprofloxacin hydrochloride 500 mg tablets were determined by weight variation, friability, hardness, disintegration, dissolution and assay tests. All the tablets were evaluated for conformity with United States Pharmacopoeia-National Formulary (USP-NF) and British Pharmacopoeia (BP) standards.ResultsAmong ten brands of tablets Brand C had lower mean weight variation of 1.59% and Brand E had highest mean weight variation of 3.32%. For friability test Brand F had lowest mean friability (0.27%) and Brand G had highest mean friability (0.54%). Among ten brands mean lowest and highest hardness were founded in Brand G (4.49 kg/cm2) and Brand F (7.13 kg/cm2) respectively. The disintegration time for ten brands of ciprofloxacin tablet obtained were in the subsequent order: Brand G (8.19 min) < Brand C (9.25 min) < Brand E (9.61 min) < Brand D (10.11 min) < Brand B (11.07 min) < Brand A (12.15 min) < Brand H (13.68 min) < Brand I (14.59 min) < Brand J (16.32 min) < Brand F (17.49 min). Among ten brands for dissolution test mean percentages of drug release were not less than 80% in 45 min for four tablets (Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%), consequently they met BP standard and as per USP-NF standard six brands (Brand B, 75.62%; Brand A, 76.18%; Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%) had released not less than 75% drugs, so they also complied with the standard. The percentages of the drug content of the ten brands of ciprofloxacin tablet were obtained in the following sequence: Brand H (96.84%) < Brand J (97.34%) < Brand D (98.15%) < Brand I (98.47%) < Brand E (99.37%) < Brand F (100.28%) < Brand B (100.38%) < Brand A (100.54%) < Brand G (101.39%) < Brand C (101.46%). All of the brands met the BP and USP-NF specifications for assay. First-order, Higuchi and Korsmeyer–Peppas kinetics model fit for all of the mentioned ten brands.ConclusionThe present study revealed that all of the leading brands of this tablet met the quality control parameters as per pharmacopoeial specifications except dissolution test for four brands (Brand J, Brand H, Brand I, and Brand F).

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Section: Methodsmentioning

confidence: 99%

In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh

et al. 2017

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“…Quality is the key issue within the pharmaceutical industry and is the part of good manufacturing practice which ensures that the essential and appropriate tests are actually carried out and that products are not released for sale or supply and consequently for human use until their quality has been arbitrated to be satisfactory according to specifications. Quality control issues are concerned with representative sampling, provisions, specification, testing along with the organization, certification, and release procedures (EudraLex, 2014;Uddin et al, 2016).…”

Section: Quality Control and Formulation Characterization: Traditionamentioning

confidence: 99%

“…The total quality of the product is assured by the IPQC and FPQC tests. This total quality assuranceÀdealing process (IPQC and FPQC tests) represents rigorous tests to allow products being completely indefectible before they are launched into the market (Uddin et al, 2015). Many concerns need to be measured in order to obtain a product with appropriate quality depending on the requirements of the national authorities and legislation, and the manufacturers' internal policies for production process (safety, marketing, etc.).…”

Section: In-process Quality Control and Finished Product Quality Contmentioning

confidence: 99%

“…Quality-control tests and standard guiding principles for pharmaceutical aerosols are obtained from pharmacopeias and regulative associations such as British Pharmacopoeia, United States Pharmacopoeia, National Formulary (USP-NF), International Pharmacopoeia, the international pharmaceutical aerosol consortium on regulation and science association, and the EPAG (Uddin et al, 2015). IPQC tests are carried out at regular intervals before the process of product manufacturing is completed.…”

Section: In-process Quality Control and Finished Product Quality Contmentioning

confidence: 99%

“…This test is repeated at least twice for each unit from the 25 sample units. Finally, the rate of valve delivery per actuation is calculated in microliters (Apiou-Sbirlea et al, 2013;Uddin et al, 2016).…”

Section: Valves Actuators and Dip Tubesmentioning

confidence: 99%

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