Quality and Pharmaceutical Equivalence Determinations of Commercially Available Amlodipine Besylate Immediate Release Tablets

Counterfeit and substandard drugs possess serious health risks. Regular quality screening is very important to ensure the standard and efficacy of pharmaceutical products. The study aimed to compare the quality of amlodipine besylate tablets available in the Bangladesh drug market and examine their physical and pharmaceutical equivalence. The various physico-chemical parameters such as diameter, shape, size, weight variation, thickness, hardness, loss on drying (LOD), friability, disintegration, dissolution, and assay have been determined according to the methods mentioned in the United States Pharmacopoeia (USP) and British Pharmacopoeia (BP). Four brands of amlodipine besylate were purchased from different local retail stores and coded as ALT1, AMT2, AMT3, and AST4 on the basis of their market share. All four brands met official USP specifications. Pharmaceutical equivalence was determined from the dissolution profile which gives acceptable difference (f1) and similarity (f2) factor values for all the brands compared with the benchmark brand for its highest market share. All the brands also met the USP criteria for assay of not less than 90.0% and not more than 110.0% of the labeled amount of amlodipine (C20H25N2O5Cl).

The influence of porosity on tablet subdivision

A tablet microstructure,especially the porosity,is a crucial parameter that influences the mechanical properties.Herein,tablet subdivisions were studied as a functi on of tablet porosity.The tablets were manufactured in the presenee of different diluents,namely microcrystalline cellulose,LudipressR,or lactose monohydrate.Furthermore,the add让ion of Camphor was investigated,which was thereafter sublimated with a view of obtaining tablets having varying degrees of porosity.Microstructural assays were corre lated to the subdivision performs nee.The increase in porosity reduced the hardness and increased the tablet friability,adversely impacting the subdivision.For all the excipients,an increase in relative porosity>90%represented the threshold level from which an inadequate subdivision occurred.The in crease in tablet porosity led to a reduction in mechanical resista nee,which,combined with a heterogeneous and disc on tinuous distribution of pores within the matrix,resulted in poor subdivision results.Con trolling tablet porosity is an important consideration when designing tablets having a subdivision purpose.

In flue nee of microwave drying and con venti onal drying methods on the mechanical properties of naproxen sodium drug tablets

Tablets are one of the most comm only used solid dosage forms taken by patients.The preparati on of high-quality tablets requires an understanding of the preparation process and elucidation of how the physical and mechanical properties change as a function of the preparation process.This work aims to investigate the impact of microwave irradiation drying and conventional drying methods(including freeze,convective and vacuum drying)on the hardness,tensile strength and friability of tablets made from a multi-component formulation containing naproxen sodium,microcrystalline cellulose,and polyvinylpyrrolidone.The results show that tablets subjected to microwave drying had the secondhighest tensile strength and hardness of 1.296 MPa and 67 N,respectively.The tablets subjected to vacuum drying had the lowest tensile strength and hardness of 1.21 MPa and 64 N,respectively.The friability index values for the tablets derived from the microwave and freeze-drying methods were<1%,while those for the tablets subjected to convective drying and vacuum drying methods were>l%.Microwave drying was observed to be an efficient method to produce naproxen sodium-containing tablets with satisfactory mechanical properties.These findings confirm that the drying method plays an essential role in the improvement or degradation of the mechanical properties of tablets.