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Preformulation studies for generic omeprazole magnesium enteric coated tablets.

C O Migoha1, M Ratansi2, E Kaale2

  • 1Tanzania Food and Drugs Authority, P.O. Box 77150, Dar es Salaam, Tanzania ; Pharm R&D Lab, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O. Box 65013, Dar es Salaam, Tanzania.

Biomed Research International
|February 21, 2015
PubMed
Summary

Preformulation studies of omeprazole magnesium revealed fair flow and compressibility, crucial for developing enteric-coated tablets. No significant drug-excipient interactions were found, ensuring formulation stability and compliance with USP standards.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Formulation Development

Background:

  • Preformulation studies are essential for the rational development of active pharmaceutical ingredients (APIs).
  • Understanding micromeritics properties of APIs guides the selection of appropriate excipients for drug formulation.
  • Omeprazole magnesium is a widely used proton pump inhibitor requiring specific formulation strategies.

Purpose of the Study:

  • To evaluate the micromeritics properties of omeprazole magnesium.
  • To assess potential drug-excipient interactions for enteric-coated tablet formulation.
  • To determine the suitability of omeprazole magnesium for pharmaceutical formulation based on preformulation data.

Main Methods:

  • Micromeritics analysis including bulk density (BD), tapped density (TD), Carr's compressibility index, and Hauser's ratio.
  • Sieve analysis was conducted to assess particle size distribution.
  • Drug-excipient compatibility studies were performed under various conditions, including spectral analysis and stability testing over 30 days.

Main Results:

  • Omeprazole magnesium exhibited fair flow and compressibility characteristics (BD: 0.4 g/mL, TD: 0.485 g/mL, Carr's index: 17.5%, Hauser's ratio: 1.2).
  • Minor color change was observed in mixtures with aerosil 200, but no significant drug degradation occurred over 30 days.
  • Moisture content varied, attributed to environmental factors; spectral changes were noted only in the visible region for omeprazole and water aerosil mixtures.

Conclusions:

  • Omeprazole magnesium possesses favorable physical properties for formulation development.
  • The drug demonstrates good compatibility with common excipients, with minimal interactions.
  • The formulation meets United States Pharmacopeia (USP) standards for fineness, flowability, and compressibility, supporting its use in enteric-coated tablets.