Mixing of low-dose cohesive drug and overcoming of pre-blending step using a new gentle-wing high shear mixer granulator.

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Mixing of low-dose cohesive drug and overcoming of pre-blending step using a new gentle-wing high shear mixer granulator.

Drug Dev Ind Pharm. 2018 May 02;:1-32

Authors: Alsulays BB, Fayed MH, Alalaiwe A, Alshahrani SM, Alshetaili AS, Alshehri SM, Alanazi FK

Abstract
The objective of this study was to examine the influence of drug amount and mixing time on the homogeneity and content uniformity of a low-dose drug formulation during the dry mixing step using a new gentle-wing high shear mixer. Moreover, the study investigated the influence of drug incorporation mode on the content uniformity of tablets manufactured by different methods. Albuterol sulphate was selected as a model drug and was blended with the other excipients at two different levels, 1% w/w and 5% w/w at impeller speed of 300 rpm and chopper speed of 3000 rpm up to 30 minutes. Utilizing a 1 ml unit side-sampling thief probe, triplicate samples were taken from 9 different positions in the mixer bowl at selected time points. Two methods were used for manufacturing of tablets, direct compression and wet granulation. The produced tablets were sampled at the beginning, middle, and end of the compression cycle. An ANOVA analysis indicated the significant effect (P < 0.05) of drug amount on the content uniformity of the powder blend and the corresponding tablets. For 1% w/w and 5% w/w formulations, incorporation of the drug in the granulating fluid provided tablets with excellent content uniformity and very low RSD (∼ 0.61%) during the whole tableting cycle compared to direct compression and granulation method with dry incorporation mode of the drug. Overall, gentle-wing mixer is a good candidate for mixing of low dose cohesive drug and provide tablets with acceptable content uniformity with no need for pre-blending step.

PMID: 29718720 [PubMed - as supplied by publisher]

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