Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market
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(2020) 13:548 Hammami et al. BMC Res Notes https://doi.org/10.1186/s13104-020-05385-8
Open Access
RESEARCH NOTE
Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market Muhammad M. Hammami1,2* , Reem AlSwayeh1 and Rajaa F. Hussein1
Abstract Objective: We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1–G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet. Results: Weight variation (range as % difference from mean), active substance content (mean (SD) as % difference from label), breaking force [mean (SD)], and friability (as % weight loss) were 95–104% and 99–102%, 100.9% (3.4%) and 105.6 (4.2%), 12.2 (1.3) and 12.9 (1.8) kg, and 0.0014% and 0.0012%, for R1 and R2, respectively. For G1-G5, they were ≤ ± 2%, 98.8% (2.7%) to 109.2% (3.8%), 6.4 (0.6) to 13.3 (1.0) kg, and 0.0007% to 0.0261%, respectively. R1 and G1-G4 disintegrated within 04:50–17:20 min: seconds and released a mean of 89–100% of label active substance content by 60 min in buffer (pH 6.8). R2 and G5 did not disintegrate or dissolve in 0.1 N HCl for 2 h, disintegrated in buffer (pH 6.8) in 01:58–02:15 h: minutes, and fulfilled dissolution criteria (pH 7.5) for both United States Pharmacopoeia test-1 and test-2. Thus all seven brands met pre-specified quality criteria. Keywords: Diclofenac potassium immediate-release, Diclofenac sodium sustained-release, Pharmaceutical quality, Saudi market, Dissolution profile, Generic brands Introduction Although the availability of generic drug products has been shown to expand healthcare accessibility and delivery [1], their quality is not infrequently questioned [2, 3]. To gain marketing approval in Saudi Arabia, generic drug products must pass standard bioequivalence testing [4]. Nevertheless, ongoing evaluation of marketed products remains crucial to protect public health and retain public and clinicians’ confidence. Such evaluation can be accomplished by in-vivo bioequivalence studies [5] or by in-vitro testing. In-vitro testing saves money and time, avoids involvement of research subjects, can forecast
*Correspondence: [email protected] 1 Clinical Studies and Empirical Ethics Department, King Faisal Specialist Hospital and Research Centre, P O Box # 3354 (MBC 03), Riyadh 11211, Saudi Arabia Full list of author information is available at the end of the article
in-vivo bioavailability, and can substitute for bioequivalence studies of certain products [6–9]. Diclofenac is a non-steroidal anti-inflammatory drug [10] that is widely marketed in Saudi Arabia [4, 11]. It is commercially available for oral administration as sodium or potassium salts, and as immediate-release, enteric-coated, and sustained-release tablet formulations. Although some of the in-vitro quality standards, such as for weight variation, f
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