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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.
Unpacking the environmental quality through the effects of natural resources, renewable energy consumption, banking development and industrial value addition: An empirical evidence from BRICS countries

Bashir MA, Qing L, Dewil R, Xi Z, Razi U, Jingting L

J Environ Manage, 2024 Sep;367:122058.
PMID: 39106799 DOI: 10.1016/j.jenvman.2024.122058

This study explores the association between natural resources rent, industrial value addition, banking development, renewable energy consumption, total reserves and environmental quality in the dynamic context of BRICS nations from 1995 to 2019. BRICS economies are responsible for global greenhouse gas emissions and confront pressing environmental challenges, including biodiversity loss and pollution. For the dependent variable, the environmental quality, the study constructed a composite index using PCA for all environmental indicators where interdependencies among variables are prevalent. Besides this, the study incorporates two interaction terms to determine the indirect influence of natural resource rent and banking development on environmental quality through the mediating role of industrial value addition. By applying the CS-ARDL technique, the outcomes of the study reveal that natural resources rent, industrial value addition, and total reserves positively influence ENQ, indicating the adverse consequences of industrial sectors on environmental quality and continued environmental degradation due to resource-intensive industrial production, underscoring the urgency of sustainable resource management. In contrast, banking development and renewable energy consumption negatively influence ENQ, signifying the positive role of developed banking sectors in supporting eco-friendly projects and enhancing environmental quality. This study offers valuable insights for policy interventions to foster a more sustainable future.

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