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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
ZUSAMMENFASSUNG

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.

MATERIALIEN
Produktnummer
Marke
Produktbeschreibung

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