A Novel Pregelatinized Starch as a Sustained-Release Matrix Excipient - Pharmaceutical Technology

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A Novel Pregelatinized Starch as a Sustained-Release Matrix Excipient
The authors examine the use of a novel highly functional pregelatinized starch as a controlled-release matrix excipient.


Pharmaceutical Technology


Conclusion

The authors conclude that HS can be applied for the development of sustained-release tablets. Experimental data confirmed the following points:

  • Drug release from HS matrix tablets was well controlled under conditions of high ionic strength and high mechanical force
  • The zero-order drug-release profile can be obtained by using a mixture of HS and PEG and is independent from drug solubility
  • The HS matrix tablets show stable drug-release profiles even under accelerated conditions
  • HS is a new matrix excipient that can control drug-release profiles from first- to zero-order sustained release and enables drug release independent of drug solubility and external conditions.

Masaaki Endo is an engineer, Kazuhiro Obae* is a chief engineer, and Yoshihito Yaginuma is a general manager, all in the Ceolus Research and Development Department at Asahi Kasei Chemicals Corporation, 1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101 Japan,

*To whom all correspondence should be addressed.

References

1. J.L. Ford et al., "Mathematical Modeling of Drug Release from Hydroxypropylmethylcellulose Matrices: Effect of Temperature,'' Int. J. Pharm. 71 (1–2), 95–104 (1991).

2. T. Tamura, "Novel Sustained Release Dosage Form Using Gel Matrix,'' Pow. Scl. Eng., 32 (5), 37–43 (2000).

3. K. Mitchell et al., "The Influence of Drugs on the Properties of Gels and Swelling Characteristics of Matrices Containing Methylcellulose or Hydroxypropylmethylcellulose,'' Int. J. Pharm. 100 (1–3), 165–173 (1993).

4. J.L. Ford et al., "Importance of Drug Type, Tablet Shape and Added Diluents on Drug Release Kinetics from Hydroxypropylmethylcellulose Matrix Tablets,'' Int. J. Pharm. 40 (3), 223–234 (1987).

5. J.L. Johnson, K. Holinej, and M. D. Williams, "Influence of Ionic Strength on Matrix Integrity and Drug Release from Hydroxypropyl Cellulose Compacts,'' Int. J. Pharm. 90 (2), 151–159 (1993).

6. K. Mitchell et al., "The Influence of Additives on the Cloud Point, Disintegration and Dissolution of Hydroxypropylmethylcellulose Gels and Matrix Tablets,'' Int. J. Pharm. 66, 233–242 (1990).

7. N. Katori, N. Aoyagi, and T. Terao, "Estimation of Agitation Intensity in the GI Tract in Humans and Dogs Based on In Vitro/In Vivo Correlation,'' Pharm. Res. 12 (2), 237–243 (1995).

8. K. Sako et al., "Influence of Physical Factors in Gastrointestinal Tract on Acetaminophen Release from Controlled-Release Tablets in Fasted Dogs,'' Int. J. Pharm. 137 (2), 225–232 (1996).

9. M. Endo, K. Obae, and Y. Yaginuma, "Application of Novel Pregelatinzed Starch as a Sustained Release Matrix Carrier,'' presented at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition, Nashville, TN, Oct. 6–10, 2005.

10. T. R. Bhardwaj et al., "Natural Gums and Modified Natural Gums as Sustained-Release Carriers,'' Drug Dev. Ind. Pharm. 26 (10), 1025–1038 (2000).

11. M. Nakano, N. Nakazono, and N. Inotsume, ''Preparation and Evaluation of Sustained Release Tablets Prepared with a-Starch,'' Chem. Pharm. Bull. 35 (10), 4346–4350 (1987).

12. J. Herman, J.P. Remon, and J. De Vilder, ''Modified Starches as Hydrophilic Matrices for Controlled Oral Delivery. I. Production and Characterization of Thermally Modified Starches,'' Int. J. Pharm. 56 (1), 61–63 (1989).

13. J. Herman, J.P. Remon, and J. De Vilder, ''Modified Starches as Hydrophilic Matrices fo Controlled Oral Delivery. II. Production and Characterization of Thermally Modified Starches,'' Int. J. Pharm. 56 (1), 65–70 (1989).

14. P. van Aerde and J P. Remon, ''In Vitro Evaluation of Modified Starches as Matrices for Sustained Release Dosage Forms,'' Int. J. Pharm. 45 (1–2), 145–152 (1988).


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