Development and Commercialization of a Novel Modified Release Tablet Technology - Pharmaceutical Technology

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Development and Commercialization of a Novel Modified Release Tablet Technology
GlaxoSmithKline recently developed a novel technology for the formulation of modified-release tablets. Commercialized as DiffCORE, the technology combines the use of apertures that are mechanically drilled into functional film-coated tablets, with traditional polymer matrices that control the mechanism of core erosion and diffusion. The authors describe the route from development to commercialization of this modified-release approach.


Pharmaceutical Technology
Volume 36, Issue 12

What are the advantages and limitations of this MR approach compared with other approaches?

Development of modified release products can be a costly activity, which may involve several clinical studies and formulation activities before a desired PK profile is obtained. There are several enabling features of this MR approach that minimizes these costs:

Advantages

  • Rapid development of multiple release rates/profiles
  • Reduction of costs associated with changes to clinical requirements
  • Production of common release profiles within a product range
  • Accommodates combination products
  • Simple manufacturing techniques
  • Elimination of technical transfer for aperture formation process
  • Full inline inspection of the quality attributes at the point of manufacture.

Disadvantages
  • An extra process during manufacturing is required
  • Specific novel equipment must be used
  • Manufacturing capacity is typically approximately 120,000 units per hour.

Conclusion

Technology development can be a risky process for a business and seems to be increasingly left to academia to prove the principles and prototype. The success of this technology within GSK shows that this need not always be the case. A small investment in targeted work can lead to advances that benefit the business as well as the patient, provided that relevant risk/benefits are monitored at all stages of the process.

Kevin D. Altria is senior scientific investigator,
, and James Taylor* is investigator,
, both with Pharmaceutical Development, GSK R&D, New Frontiers Science Park, Third Avenue, Harlow, Essex, CM19 5AW, UK.

*To whom all correspondence should be addressed.

Submitted: Feb. 15, 2012. Accepted: Mar 15, 2012.

Dedication

This article is dedicated to the memory of Dr. John Hempenstall who greatly supported the development and commercialization of this technology. John was a great friend and mentor to many GSK colleagues.

References

1. C.L. Li et al., J. Pharm. Pharmacol. 57 (5) 533–546 (2005).

2. U. Conte et al., J. Control. Rel. 26 (1) 39–47 (1993).

3. US Patent Application 20110135695, "Oral Dosage Form for Controlled Drug Release," filed Dec. 2010, Inventors: C.L. Li et al, Assignee: Glaxo Group Limited.

4. S.R. Vaithiyalingam and V.A. Sayeed, J. Pharm. 398 (1–2) 9–13 (2010).

5. F. Theeuwes, J. Pharm. Sci. 64 (12) 1987–1991 (1975).

6. J. Shokri, Eur. J. Pharm. Biopharm. 68 (2) 289–297 (2008).

7. D.R. Reynolds, S.A. Mitchell and K.M. Balwinski, Drug Dev. Ind. Pharm. 28 (4) 457–466 (2002). PT


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