Spray dried excipient base: a novel technique for the formulation of orally disintegrating tablets

Chem Pharm Bull (Tokyo). 2006 Jan;54(1):99-102. doi: 10.1248/cpb.54.99.

Abstract

Orally disintegrating tablets (ODT) are gaining popularity over conventional tablets due to their convenience in administration and suitability for patients having dysphagia. Moreover no water is required for swallowing the tablets and hence suitable for geriatric, pediatric and traveling patients. The purpose of this study is to assess the suitability of spray dried excipient base in the formulation of ODTs of Valdecoxib (low aqueous solubility) and Metoclopramide (high aqueous solubility). Spray dried excipient base was prepared using Scientech spray drier. Super disintegrants (such as Ac-Di-Sol, Kollidon CL, sodium starch glycolate), diluent (mannitol) alongwith sweetening agent (aspartame) were used in the formulation of tablets. The tablets were evaluated for hardness, friability, water absorption ratio, disintegration time (DT) and in vitro drug release. Using the same excipients, the tablets were prepared by direct compression and were evaluated in the similar way. Maximum drug release and minimum DT were observed with Kollidon CL excipient base as compared to tablets prepared by direct compression, showing the superiority of the spray dried excipient base technique over direct compression technique.

MeSH terms

  • Absorption
  • Chemistry, Pharmaceutical / methods*
  • Cyclooxygenase 2 Inhibitors / administration & dosage
  • Cyclooxygenase 2 Inhibitors / chemistry
  • Desiccation / methods*
  • Dopamine Antagonists / administration & dosage
  • Dopamine Antagonists / chemistry
  • Excipients / chemistry*
  • Hardness Tests
  • Isoxazoles / administration & dosage
  • Isoxazoles / chemistry
  • Metoclopramide / administration & dosage
  • Metoclopramide / chemistry
  • Microscopy, Electron, Scanning
  • Particle Size
  • Solubility
  • Sulfonamides / administration & dosage
  • Sulfonamides / chemistry
  • Tablets*

Substances

  • Cyclooxygenase 2 Inhibitors
  • Dopamine Antagonists
  • Excipients
  • Isoxazoles
  • Sulfonamides
  • Tablets
  • valdecoxib
  • Metoclopramide