Abstract
Acyclovir, an anti-viral drug widely used in the treatment of herpes simplex virus infections, characterized by low aqueous solubility. The present study focuses on the formulation and evaluation of Acyclovir fast dissolving tablets which offer a solution for those patients having difficulty in swallowing. In the formulation of fast dissolving tablets of acyclovir, superdisintegrants like starch phthalate (a novel superdisintegrant), croscarmellose sodium and crospovidone are employed. The synthesized starch phthalate was characterized by FTIR, X-ray etc. The Acyclovir - Starch phthalate compatibility studies like DSC, FTIR and TLC were done. From the results, it was observed that no chemical interaction between the drug and starch phthalate confirmed. 23 factorial design was used in formulation of tablets to obtain the ideal concentration of starch phthalate that is to be used in the formulation of fast dissolving tablets with less experimentation and in short period of time. Acyclovir fast dissolving tablets were subjected to various physical tests and in-vitro dissolution studies. The studies revealed that concentration of 10% w/w of starch phthalate can be used as superdisintegrant in the formulation of fast dissolving of fast dissolving tablets. Keywords: Acyclovir, Starch phthalate, Fast Dissolving Tablets, 23factorial design, Superdisintegrant.
Highlights
The Center for Drug Evaluation and Research (CDER), US FDA defined Fast dissolving/disintegrating tablets (FDDTs) are “ A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue”
Preparation of Starch Phthalate (A Novel Superdisintegrant): Initially Phthalic anhydride was dissolved in 2ml of dimethyl sulphoxide (DMSO) and the pH was adjusted to 3.5 using 10M NaOH and made upto 50ml
Insoluble in all aqueous and organic solvents tested 2.88 Charred at 3250C 1.08cps 65% No gelling and the swollen particles of starch phthalate separated from water
Summary
The Center for Drug Evaluation and Research (CDER), US FDA defined Fast dissolving/disintegrating tablets (FDDTs) are “ A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue”. Fast Disintegrating Tablets (FDT) are known as ‘fast dissolving’, ‘mouth dissolving’, ‘rapid dissolve’, ‘quick disintegrating’, ‘orally disintegrating’, ‘rapimelt’, ‘fast melts’, ‘orodispersible’, ‘melt-inmouth’, ‘quick dissolving’, ‘porous tablets’, ‘EFVDAS’ or ‘ Effervescent Drug Absorption System’. The basic approach in development of FDT is the use of superdisintegrants like cross linked or carboxy methyl cellulose (crosscarmellose), sodium starch glycolate (primogel, explotab) cross linked polyvinyl pyrrolidone (crospovidone) etc., which provide instantaneous disintegration of tablet after putting on tongue, their by release the drug in saliva.
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