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
- 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.
- An extra process during manufacturing is required
- Specific novel equipment must be used
- Manufacturing capacity is typically approximately 120,000 units per hour.
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, email@example.com
and James Taylor* is investigator, firstname.lastname@example.org
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.
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.
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