MyMedR

Displaying all 2 publications

Abstract:

Sort:

Bioequivalence assessment of two enteric-coated aspirin brands, Nu-Seals and Loprin, after a single oral dose of 150 mg in healthy male adults

Bukhari NI, Zafar A, Shamsi Wu, Bashir MA, Mirza AA

Therapie, 2005 Mar-Apr;60(2):167-73.
PMID: 15969319

AIM: The bioequivalence of aspirin from two enteric-coated brands, Nu-seals and Loprin, identified as the reference (R) and test (T) products, respectively, was assessed.

METHODS: A two-period randomised crossover design with a washout interval of 15 days was used in this study. The study results were determined in 16 healthy volunteers, all males with ages ranging from 19-28 (23.33 +/- 3.74) years and bodyweights of 52-92 (65.89 +/- 11.39) kg. After oral ingestion of 150mg of the either brand with 200 mL of water, serial blood samples were obtained over a period of 24 hours. Plasma, harvested from blood was analysed for the concentration of salicylic acid, a deacetylated metabolite of aspirin, by a validated high performance liquid chromatography (HPLC) method. Pharmacokinetic parameters were determined for both formulations by an interactive computer-assisted PK II procedure. A general linear model for repeated measures and 90% confidence intervals (CI) was employed to assess the sequence of treatment effects and to exclude differences between the parameters due to the product and period of administration, respectively.

RESULTS: The observed 90% CI ratios (Loprin/Nu-seals) for peak concentration, time to reach the peak and area under the plasma-concentration time curve from zero to infinity of 1.03,1.08; 1.04,1.05 and 1.01,1.15, respectively, were within the bioequivalence range (0.80,1.25) stipulated by the US Food and Drug Administration.

CONCLUSION: On the basis of the findings, the test (Loprin) and reference drug (Nu-seals) were deemed bioequivalent.
Fulltext Development and Evaluation of Self-Emulsifying Drug-Delivery System-Based Tablets for Simvastatin, a BCS Class II Drug

Bashir MA, Khan A, Shah SI, Ullah M, Khuda F, Abbas M, et al.

Drug Des Devel Ther, 2023;17:261-272.
PMID: 36726738 DOI: 10.2147/DDDT.S377686

BACKGROUND: Self-emulsifying drug-delivery systems (SEDDSs) are designed to improve the oral bioavailability of poorly water-soluble drugs. This study aimed at formulating and characterization of SEDDS-based tablets for simvastatin using castor and olive oils as solvents and Tween 60 as surfactant.
METHODS: The liquids were adsorbed on microcrystalline cellulose, and all developed formulations were compressed using 10.5 mm shallow concave round punches.
RESULTS: The resulting tablets were evaluated for different quality-control parameters at pre- and postcompression levels. Simvastatin showed better solubility in a mixture of oils and Tween 60 (10:1). All the developed formulations showed lower self-emulsification time (˂200 seconds) and higher cloud point (˃60°C). They were free of physical defects and had drug content within the acceptable range (98.5%-101%). The crushing strength of all formulations was in the range of 58-96 N, and the results of the friability test were within the range of USP (≤1). Disintegration time was within the official limits (NMT 15 min), and complete drug release was achieved within 30 min.
CONCLUSION: Using commonly available excipients and machinery, SEDDS-based tablets with better dissolution profile and bioavailability can be prepared by direct compression. These S-SEDDSs could be a better alternative to conventional tablets of simvastatin.

Filters

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links