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  • Freeze drying: exploring potential in development of orodispersible tablets of sumatriptan succinate.

Freeze drying: exploring potential in development of orodispersible tablets of sumatriptan succinate.

Drug development and industrial pharmacy (2014-01-05)
Dalapathi Gugulothu, Preshita Desai, Pranav Pandharipande, Vandana Patravale
ABSTRACT

The present investigation is aimed at development and characterization of sumatriptan succinate orodispersible tablets (ODTs) prepared by freeze drying technology. The tablet excipients were screened and the composition was optimized based on parameters which involved general appearance, tablet size and shape, uniformity of weight, mechanical properties, surface pH, moisture analysis, drug content, wetting time, in vitro and in vivo disintegration time. Furthermore, fourier transform infrared spectroscopy, differential scanning calorimetry, scanning electron micrograph of cross-section of the tablet and in vitro dissolution studies were performed. Studies revealed that formulation containing gelatin-mannitol (3.75% w/v and 3.5% w/v, respectively) with camphor as a volatile pore forming agent exhibited superior properties with disintegration time of less than 10 s. Furthermore, in vitro release studies revealed 90% release of drug from developed dosage form within 10 min, thus suggesting rapid drug dissolution followed by faster onset of action, which forms a strong rationale for development of ODTs of sumatriptan succinate. The developed technology is simple, which involves few steps and can be easily scaled up. Thus, it holds enormous potential for commercial exploitation.

MATERIALS
Product Number
Brand
Product Description

Sumatriptan succinate, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Sumatriptan succinate, ≥98% (HPLC), solid
USP
Sumatriptan succinate, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Glycine, ReagentPlus®, ≥99% (HPLC)
Sigma-Aldrich
Glycine, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
Sigma-Aldrich
Glycine, ACS reagent, ≥98.5%
Sigma-Aldrich
Glycine, meets analytical specification of Ph. Eur., BP, USP, 99-101% (based on anhydrous substance)
Sigma-Aldrich
Glycine, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
Glycine, puriss. p.a., reag. Ph. Eur., buffer substance, 99.7-101% (calc. to the dried substance)
Sigma-Aldrich
Glycine, tested according to Ph. Eur.
SAFC
Glycine
Sigma-Aldrich
Glycine, BioXtra, ≥99% (titration)
Sigma-Aldrich
Glycine, suitable for electrophoresis, ≥99%
Sigma-Aldrich
Glycine, 99%, FCC
Supelco
Glycine, analytical standard, for nitrogen determination according to Kjeldahl method
Supelco
Glycine, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Glycine, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland
Sumatriptan for system suitability, European Pharmacopoeia (EP) Reference Standard
USP
Glycine, United States Pharmacopeia (USP) Reference Standard
Glycine, European Pharmacopoeia (EP) Reference Standard