In Vitro Assessment of Quality Control Parameters of Some Commercially Available Generics of Amlodipine Besylate in Nigerian Drug Market

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109

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In vitro susceptibility testing and quality control parameters for sarafloxacin (A-56620): a fluoroquinolone used for treatment and control of colibacillosis in poultry

Diagnostic Microbiology and Infectious Disease ◽

10.1016/s0732-8893(98)00063-7 ◽

1998 ◽

Vol 32 (1) ◽

pp. 55-64 ◽

Cited By ~ 7

Author(s):

Ronald N. Jones ◽

Meridith E. Erwin

Keyword(s):

Quality Control ◽

Susceptibility Testing ◽

Control Parameters ◽

In Vitro Susceptibility ◽

Quality Control Parameters ◽

In Vitro Susceptibility Testing ◽

And Control

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In-Vitro Comparative Quality Evaluation of Marketed Cefuroxime 250 mg Tablets in Bangladesh

European Journal of Medical and Health Sciences ◽

10.34104/ejmhs.020012015 ◽

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.

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Consumers’ Perception of Generic Medicines and Evaluation of In Vitro Quality Control Parameters of Locally Manufactured Paracetamol Tablets in Asmara, Eritrea: A Cross-Sectional Study

BioMed Research International ◽

10.1155/2021/6642826 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Idris Mohammed Idris ◽

Diyae Nesredin Hassan ◽

Hanan Abdelkadir Hassen ◽

Rahwa Zerabruk Araya ◽

Dawit G. Weldemariam

Keyword(s):

Quality Control ◽

Generic Medicine ◽

Cross Sectional Study ◽

In Vitro Test ◽

Control Parameters ◽

Sectional Study ◽

Generic Medicines ◽

Cross Sectional ◽

Quality Control Parameters

Generic medicines are clinically equivalent and can be used interchangeably for their intended use. Globally, the usage of generic medicines is highly recommended because of their affordability and accessibility. However, consumers hold a negative perception and attitude of using generic medicine as they consider it poor and having inferior quality compared to branded medicines. This study was conducted to assess the consumers’ general view of generic medicines and in vitro evaluation of a locally produced generic medicine, paracetamol. An analytical and cross-sectional study was conducted in three selected hospitals, and in vitro quality control evaluation was done in National Drug Quality Control Laboratory between October 26 and November 21, 2017, in Asmara, Eritrea. A systematic random sampling design was employed, and the data was collected using a questionnaire and a check-list for recording the quality control parameters of paracetamol tablets. A total of 403 respondents were included in the study. The majority of the study participants were females (61.8%). Generally, about half (49.1%) of the respondents choose locally manufactured paracetamol over the imported ones. More than half (68.5%) of the respondents did not believe expensive medicines are of better quality. The main reason consumers prefer the local paracetamol (Azemol) tablet to the imported one was due to their good experience (62.1%). About three-fourths (78.1%) of the consumers also believed that medicines manufactured abroad confer higher quality. At the multivariate level, having educational backgrounds such as elementary ( AOR = 4.19 , 95% CI: 1.251, 14.035) and junior ( AOR = 2.4 , 95% CI: 1.146, 5.028) was associated with preferability to local paracetamol as a pain killer over the brand ones. The in vitro test of the local paracetamol met the standard specification for the identification test, weight variation test, pharmacopeial test, friability test, disintegration test, and dissolution test. In conclusion, the majority of the consumers considered local paracetamol as having an inferior quality when compared with brand paracetamol. However, the reality revealed that the local paracetamol was of the same quality as the brand ones. To facilitate widespread use of generic medicines, healthcare professionals should educate consumers on the advantages of these medicines.

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