Fromsa, Muluneh (2010) Stability and Comparative Dissolution Studies of Five Brands of Norfloxacin Tablets Marketed in Addis Ababa. Masters thesis, Addis Ababa University.
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Abstract
Norfloxacin is hygroscopic and can under go polymorphic change upon exposure to high relative humidity. Currently, many different brands of norfloxacin tablets are available in local market, Addis Ababa, Ethiopia. The quality of these brands may vary with time under the influence of a variety of environmental factors such as temperature and humidity, and also a brand with poor quality may exist. The availability of many brands and the susceptibility of the active ingredient of norfloxacin tablets to environmental factors are the major reasons for evaluating the quality and stability of the tablets. Dissolution profile is a very important quality parameter for solid oral dosage forms. Furthermore, the purpose of stability testing is to provide evidence on how the quality of a drug substance or a drug product varies with time under the influence of a variety of environmental factors. Accordingly, the objective of the present study is to compare the dissolution profiles of five different brands of norfloxacin tablets with that of the innovator and study the stability of the five brands of norfloxacin tablets under the influence of accelerated conditions (40 0C and 75% RH). Norfloxacin 400 mg film coated tablets of six different brands, A, B, C, D, E and F (codes given to the brands) were purchased from Addis Ababa, Ethiopia. The tablets were assessed for physical and chemical parameters immediately after purchase. At the same time, these samples were stored in an accelerated stability cabinet maintained at 40 0C + 2 0C and 75% + 5% RH. Then, the physical and chemical stability parameters were tested at three and six months according to International Conference on Harmonization (ICH) Guidelines. The t50% and t90% (time required for releasing 50% and 90% of the drug, respectively) were used as dissolution parameters to compare dissolution profiles. The t50% results indicated that except for Product C all the products released 50% of the drug below 10.2 min (the time taken by the innovator product to release 50%). However, the values of t90% for three products (B, C, and E) were longer (42.1, 37.4 and 29.0 min, respectively) than that of the innovator product (17.6 min) showing slower dissolution rates relative to the latter. On the other hand, product D released 90% at 9.8 min showing faster rate of dissolution than the innovator product. The stability testing indicated that during the six months storage physical changes like film cracking, decrease in hardness, increase in moisture content and changes in dissolution profiles were observed. These were mainly due to moisture sorbed by the products. The highest change in drug content was 3.6% at six-month, less than 5%. Accordingly, no significant change in drug content occurred in any of the investigated norfloxacin tablet product stored under conditions of 40 0C + 2 0C and 75% + 5% RH for six months.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Norfloxacin, Film coated tablet, Dissolution profile, Stability, Accelerated conditions |
| Subjects: | R Medicine > RS Pharmacy and materia medica |
| Divisions: | Africana |
| Depositing User: | Vincent Mpoza |
| Date Deposited: | 21 Jun 2018 06:23 |
| Last Modified: | 21 Jun 2018 06:23 |
| URI: | http://thesisbank.jhia.ac.ke/id/eprint/5223 |
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