Friday , 23 October 2020

Fabrication and in vitro evaluation of Venlafaxine Hydrochloride mini tablets filled hard Gelatin Capsules

About author
Dr. Hindustan Abdul Ahad*, Anusha N, Naresh babu G, Anil Kumar K
PG department of Industrial Pharmacy, Balaji College of Pharmacy, Anantapur, AP, India
E-mail: abdulhindustan@rediffmail.com

Abstract
The main objective of present work is to develop mini tablets filled hard gelatin capsules. Mini tablets filled hard gelatin capsules drug delivery system comprises of 5 matrix mini-tablets weighing 50 mg encapsulated in hard gelatin capsule (size 00). For achieving the sustained release, various viscosity grades of Hydroxy propyl methyl cellulose polymer (HPMC K4M, K100M, K200M) and Kollidone were used. The mini-tablets were prepared by wet granulation method. The prepared mini-tablets were subjected for pre-compressional and post-compressional evaluation. The compatibility of drug with ingredients used were checked by DSC and FTIR studies. Accelerated stability studies were carried out as per ICH guidelines for the best formulation. The pre-compression and post compression parameters were within prescribed limits. The in vitro performance of the best formulation showed sustained drug release for a period of 12 h. The DSC and FTIR results revealed that there was no interaction between dug and excipients used. The best formulation retained its physicochemical characteristics even after stressed storage conditions.
Key words: Mini-tablets, hard gelatin Capsule, Hydroxy propyl methyl cellulose, Kollidone 
Introduction
The concept of multi-unit dosage forms were initially introduced in the early 1950s. They show reproducibility of the sustained release profiles when compared single unit dosage forms. In multi-unit dosage forms the dose is administered as a number of subunits, each one containing the drug. The dose is then the sum of the quantity of the drug in each subunit and the functionality of the entire dose is directly correlated to the functionality of the individual subunits. The normal size of mini tablets are with a diameter of 3mm. From the production point of view mini tableting technique has advantages over pellets, as it does not require any solvents for its production, defined size and strengths can easily be produced with good batch to batch uniformity. Mini tablets filled into hard capsules, after disintegration, release these subunits as multiple dosage forms. Venlafaxine Hydrochloride is a unique. Venlafaxine HCl and its active metabolite, o-desmethylvenlafaxine (ODV), inhibit the neuronal uptake of norepinephrine, serotonin and to a lesser extent dopamine,  but have no monoamine oxidase inhibitory activity and a low affinity for brain muscarinic, cholinergic, histaminergic or alpha adrenergic receptors. Hence, it lacks the adverse anticholinergic, sedative and cardiovascular effects of tricyclic antidepressants. The steady state half-lives of Venlafaxine HCl and ODV are 5h and 11h, respectively, necessitating the administration, 2 or 3 times daily so as to maintain adequate plasma levels of drug.

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