Quality Assessment of Nineteen Brands of Ciprofloxacin Tablets Commercially Available in Lagos, Nigeria
Sunday, March 2, 2025 10:10 AM to 10:30 AM · 20 min. (America/New_York)
Room 207
Oral
Pharmaceutical & Biologics
Information
The need to select one product from several generic drug products of the same active ingredients during therapy is a cause of concern to a healthcare practitioner.
The objectives of this study are to evaluate the quality of nineteen brands of Ciprofloxacin tablets commercially available in Lagos and to determine the brands that can be used interchangeably with the innovator brand.
The uniformity of weight, hardness test, friability test, disintegration test, dissolution test and the assay using the HPLC with UV detector were carried out in conformity with the United States Pharmacopoeia.
All brands analyzed complied with the official specification for hardness and disintegration. Two brands, Cipro 03 and Cipro 17 failed the uniformity of weight test. One brand, Cipro 12 failed the friability test as its friability was greater than 1%. The dissolution test profile also revealed that two brands, Cipro 03 and Cipro 05, failed the test, they did not release up to 80% of their active ingredient at 30 mins in accordance with the Pharmacopoeia. The dissolution profile of the brands was also compared using their similarity factor and difference factor. The analysis shows that Cipro 06, 07, 08, 09, 10, 13, 14 & 16 can be used interchangeably with the innovator brand, Cipro 01, considering their similarity factor (f2) and difference factor (f1) were within the acceptable range of 50-100 and 0-15 respectively as stated by the FDA. Six brands failed the percentage purity test, Cipro 03 and Cipro 17 were below the required standard while Cipro 08, Cipro 11, Cipro 12, Cipro 16 were above. They did not comply with the official percentage purity range, 90%-110%, specified in the United States Pharmacopoeia.
From the result above, it was observed that some brands of Ciprofloxacin sold in Lagos are sub-standard. Therefore, it is imperative to carry out the quality assessment of medicinal agents to ensure their potency, efficacy and safety for consumers.
The objectives of this study are to evaluate the quality of nineteen brands of Ciprofloxacin tablets commercially available in Lagos and to determine the brands that can be used interchangeably with the innovator brand.
The uniformity of weight, hardness test, friability test, disintegration test, dissolution test and the assay using the HPLC with UV detector were carried out in conformity with the United States Pharmacopoeia.
All brands analyzed complied with the official specification for hardness and disintegration. Two brands, Cipro 03 and Cipro 17 failed the uniformity of weight test. One brand, Cipro 12 failed the friability test as its friability was greater than 1%. The dissolution test profile also revealed that two brands, Cipro 03 and Cipro 05, failed the test, they did not release up to 80% of their active ingredient at 30 mins in accordance with the Pharmacopoeia. The dissolution profile of the brands was also compared using their similarity factor and difference factor. The analysis shows that Cipro 06, 07, 08, 09, 10, 13, 14 & 16 can be used interchangeably with the innovator brand, Cipro 01, considering their similarity factor (f2) and difference factor (f1) were within the acceptable range of 50-100 and 0-15 respectively as stated by the FDA. Six brands failed the percentage purity test, Cipro 03 and Cipro 17 were below the required standard while Cipro 08, Cipro 11, Cipro 12, Cipro 16 were above. They did not comply with the official percentage purity range, 90%-110%, specified in the United States Pharmacopoeia.
From the result above, it was observed that some brands of Ciprofloxacin sold in Lagos are sub-standard. Therefore, it is imperative to carry out the quality assessment of medicinal agents to ensure their potency, efficacy and safety for consumers.
Day of Week
Sunday
Session or Presentation
Presentation
Session Number
OR-06-03
Application
Pharmaceuticals
Methodology
Process Analytical Techniques
Primary Focus
Application
Morning or Afternoon
Morning
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