Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation
| Autor: | Syed N. Alvi, Muhammad M. Hammami, Reem Al-Swayeh, Rajaa F Hussein |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Diclofenac
Chemistry Pharmaceutical Saudi Arabia lcsh:Medicine Friability General Biochemistry Genetics and Molecular Biology 03 medical and health sciences In-vitro quality 0302 clinical medicine Animal science Medicine Immediate-release 030212 general & internal medicine Immediate release Enteric coated lcsh:Science (General) lcsh:QH301-705.5 Dissolution profile business.industry lcsh:R Phosphate buffered saline General Medicine Diclofenac Sodium Substance content Research Note Diclofenac sodium tablet lcsh:Biology (General) Solubility 030220 oncology & carcinogenesis Generic formulations Tablets Enteric-Coated business lcsh:Q1-390 Tablets |
| Zdroj: | BMC Research Notes, Vol 13, Iss 1, Pp 1-6 (2020) BMC Research Notes |
| ISSN: | 1756-0500 |
| Popis: | Objective To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. Results A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25–75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97–103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99–103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69–90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia. |
| Databáze: | OpenAIRE |
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