Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply - Pharmaceutical Technology

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Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply
To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.


Pharmaceutical Technology


Conclusion

The methods of active pharmaceutical ingredient in a capsule, drug in a bottle, liquid in a capsule, or multiple binary blends provide options for getting drug product into the clinic in a short period of time. Although not all the options are capable of reaching commercial scale, they are all capable of supporting early clinical studies and may be used as a path to an eventual commercial dosage form.

Acknowledgment

The author is thankful to Paul Skultety, director of pharmaceutical development services at Xcelience for final review.

Balaji V. Kadri is a manager of the preformulation and formulation-development department at Xcelience, 5415 West Laurel St., Tampa, FL 33647, tel. 813.286.0404, fax 813.286.1105,

References

1. C.H. Dubin, "Formulation Strategies for Poorly Soluble Drugs," Drug Del. Technol. 6 (6), 34–38 (2006).

2. "Xcelodose S Precision Powder Mircodosing System," available at http://www.capsugel.com/pdf/xceloSBorchure.pdf, accessed July 17, 2008.

3. O.J. Murray, W. Dang, and D. Bergstrom, "Using an Electronic Tongue to Optimize Taste-Masking," Pharm. Technol., Outsourcing Resources suppl. 42–52 (Aug. 2004).

4. I. Alashkar, "It Tastes like Medicine," Pharma Quality 30–37 (Dec.–Jan., 2006).

5. M.E. Martelli, "Sublingual and Buccal Medication Administration," in Encyclopedia of Nursing and Allied Health (Thomson Gale, Farmington Hills, MI, 2008), pp. 1–9.

6. J.A. Nicollazzo and B.C. Finnin, "In Vivo and In Vitro Models for Assessing Drug Absorption Across the Buccal Mucosa," in Biotechnology: Pharmaceutical Aspects, vol. VII (Springer US, New York, 2007), pp. 89–111.

7. T.E. Cole, "Liquid Filled and Sealed Hard Gelatin Capsules," Capsugel Library (2000).

8. "Liquid Encapsulation Microspray Sealing (LEMS)," available at http://www.capsugel.com/equipment/cfs1200.php, accessed July 17, 2008.

9. Gattefossé. "Solubility and Bioavailability Enhancers," available at http://www.gattefosse.com/internet/gatt-wk3.nsf/TECHDOCPARCLEF/00000309?OpenDocument&Menu=1/, accessed June 19, 2008.

10. M. Richardson and S. Stegemann, "Filling Two-Piece Hard Gelatin Capsules with Liquids," Tablets & Capsules 3 (1), 97–110 (2006).


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