Evaluation of Critical Quality Attributes of Immediate Release Ciprofloxacin Tablets of Different Pharmaceutical Companies in Bangladesh
| Autor: | Sreebash Chandra Bhattacharjee, Dipankar Chakraborty, Paroma Arefin, Rezvi Ahmed, Dip Bhowmik, Suman Das, Debabrata Karmakar, Shehan Habib |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
business.industry
02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Biotechnology Ciprofloxacin 03 medical and health sciences 0302 clinical medicine Drug Discovery medicine Immediate release 0210 nano-technology business Critical quality attributes Agronomy and Crop Science medicine.drug |
| Zdroj: | Biosciences Biotechnology Research Asia. 17:781-788 |
| ISSN: | 2456-2602 0973-1245 |
| Popis: | Critical Quality Attributes (CQAs) is an important factor in Pharmaceutical development as it determines the strength, release of the API from SDFs, and stability of a pharmaceutical dosage form. Moreover, substandard and counterfeit drugs have been a major concern in recent days.Ciprofloxacin is a second-generation fluoroquinolone derivative that exerts its effects by inhibiting bacterial DNA gyrase (Topoisomerase II). It is used for the treatment of bacterial gastroenteritis, respiratory tract infections, controlling bronchitis and pneumonia caused by Gram negative bacteria. Ciprofloxacin has been listed in the World Health Organization (WHO) Model list of Essential Medicines. In recent decades, the pharmaceutical industry has been experiencing excellent growth in both local and international market.In our present study, we have analyzed theCritical Quality Attributes (CQAs) including length, thickness, friability, weight variation, hardness test and disintegration time of Ciprofloxacin tablet to study whether the ciprofloxacin immediate release tablets of different pharmaceutical companies available in the Bangladeshi market to assess whether they are compliant to BP or USP guidelines in respect of physical parameters. We have also performed statistical analysis and found that that all the tablets from different brands are within the BP or USP requirements. So, from the study, we reached the conclusion that the critical quality attributes for ciprofloxacin immediate release tablets of different pharmaceutical companies in Bangladesh ensure the appropriateness of their strength, purity, release of the API from SDFs, and stability. |
| Databáze: | OpenAIRE |
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