ACCELERATED STABILITY STUDY AND MICROBIOLOGICAL TESTS ON NEW ORAL MATRIX DELIVERY SYSTEMS FOR DICLOFENAC SODIUM
Abstract
An accelerated stability study was performed on diclofenac sodium controlled release matrix tablets (MT20,MT33,MT34,MT33p,MT34p ) containing natural gums, semi-synthetic gum , Eudragit L100,and hydroxypropylmethylcellulose (HPMC).Drug content was found to be in the range of 90-105% in all the five matrix formulas. Applying out of stability trend rules (OOT), the best formula was found to be MT33 which contained Guar gum 15%, and gum Arabic15%. No changes in physical appearance, or organoleptic properties were observed. Microbiological tests for the five matrix tablets were evaluated (1). No growth (bacteria or fungi) was detected, in preserved or non-preserved formulas despite of the gum content in these controlled release tablets
References
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Pharmaceutical Technology 2003 pages 38-52
2. Herbert A. L., Leon L., And Josef B. S. Pharmaceutical Dosage forms Tablets Vol 3, 1992 pages 457-496.
3. Alfred M., Physical pharmacy 4th edition. Lippincott Williams and Wilkins, 351 West Camden Street, Baltimore Maryland, USA.2001.pages 313-323.
4. WHO. Working document QAS/04.088. 2004 pages 1-11.
5. Singh Sarajit., Pharmatimes, 29, 1997, pages 29-42.
6. Singh, Sarajit, East.pharm, 60 (479) 1997, pages 41-42.
7. Singh, Sarajit, East.pharm, 61(487), 1998, pages 43-48.
8. Technical report, series, 863, WHO, Geneva, Switzerland. WHO 1996.
9. Haynes, J.D 1971. J.pharm.Sci, 60, 1971, pages 927-929.
10. Monika Bakashi, and Sarajit sigh, ICH guidance in practice, stress degradation studies on metronidazole and development of a validated stability-indicating HPLC assay method. Pharmaceutical Technology, .2003, pages 148-160.
11. Kulkarni.G.T et al. Pharmaceutics .Stability testing of pharmaceutical products: An overview. Pharmaeutics Vol 38 Nubber 04, 2004.pages 1-3.
12. BP 2001
13. BP Appendix XV1D.Category 3. 1999 pages 1-2.
14. A.A.A. Gargar and Abdulkarim M.A. In vitro Diclofenac soium dissolution profile in new matrix delivery systems. Omdurman Journal of pharmaceutical Sciences (OJPS) No 2, 2006.pages 125-134.
15. Pharmaceutical Excipients, American Pharmaceutical association, And the Pharmaceutical Society of Great Britain. Printed in USA.
16. Kurup T.R.R Microbiological quality in pharmaceuticals. The eastern pharmacist. 1981, pages 53-69.
17. Hemant Bhagani, Mariappan T.T. and Sarajit S. Behavior of uptake of moisture by drugs and excipients under accelerated conditions of temperature and humidity in absence and presence of light.Pharmaceutical technology, 2003. Pages 44-52.
18. Harpinter Kaur et al. Uptake of moisture by drug and excipients. Pharmaceutical technology. 2003, pages 52-56
19. RhRMACMC Statistics and Stability Expert teams. Identification of outof-Trend stability results, a review of the potential regulatory issue and various approaches. RhRMACMC Statistics and Stability Expert teams.
Pharmaceutical Technology 2003 pages 38-52
Published
2006-12-01
How to Cite
ABDALLA GARGAR, Abdalla A.; ELNIMA, Elamin Ibrahim; ABDULKARIM, Abdulkarim M..
ACCELERATED STABILITY STUDY AND MICROBIOLOGICAL TESTS ON NEW ORAL MATRIX DELIVERY SYSTEMS FOR DICLOFENAC SODIUM.
Gezira Journal of Health Sciences, [S.l.], v. 2, n. 2, dec. 2006.
ISSN 1810-5386. Available at: <http://37.60.236.48/index.php/gjhs/article/view/698>. Date accessed: 03 june 2026.
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