Formulation development of ambroxol hydrochloride soft gel with application of statistical experimental design and response surface methodology

PDA Journal of Pharmaceutical Science and Technology

Volumn 65, Issue 1, 2011, Pages 20-31

  Dabhi, Mahesh ^a   Gohel, Mukesh ^b   Parikh, Rajesh ^b   Sheth, Navin ^a   Nagori, Stavan ^b  

^a SAURASHTRA UNIVERSITY   (India)

^b L M COLLEGE OF PHARMACY   (India)

Author keywords

Ambroxol hydrochloride; Experimental design; Gellan gum; Immediate release; Soft gel

Indexed keywords

AMBROXOL; CITRATE SODIUM; GELLAN; DELAYED RELEASE FORMULATION; GEL;

ACETYLATION; ARTICLE; DRUG DESIGN; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; FLOW KINETICS; GELATION; IN VITRO STUDY; PH; RESPONSE SURFACE METHOD; VISCOSITY; CHEMISTRY; DELAYED RELEASE FORMULATION; GEL; HUMAN; MEDICINAL CHEMISTRY; METHODOLOGY;

AMBROXOL; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; GELS; HUMANS; RESEARCH DESIGN; VISCOSITY;

EID: 80052973084     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Lewis, G. A.; Mathiue, D.; Phan-Tan-Luu, R. Pharmaceutical Experimental Design; Marcel Dekker, Inc.: New York, 1999; p 112.
2. Kaushik, D.; Dureja, H.; Saini, T. R. Mouth dissolving tablets: a review. Indian Drugs 2004, 41 (4), 187-193.
3. Habib, W.; Khanhari, R.; Hontz, J. Fast-dissolve drug delivery systems. Crit. Rev. Ther. Drug Carrier Sys. 2000, 17 (1), 61-72. (Pubitemid 30174149)
4. Bertelsen, P.; Hansen, N. G.; Ruckendorfer, H.; Itai, S. Quick Release Pharmaceutical Compositions of Drug Substances. U.S. Patent 6,713,089, 2004.
5. Abu-Izza, K. A.; Li, V. H.; Look, J. L.; Parr, G. D.; Schineller, G. A. Fast Dissolving Tablet. U.S. Patent 6,733,751, 2004.
6. R. H. Bogner et al. Fast-dissolving tablets. Welcome to US pharmacist, 2003.
7. Watanabe, Y.; Koizumi, K.; Zama, Y.; Kiriyama, M.; Matsumoto, Y.; Matsumoto, M. New compressed tablet rapidly disintegrating in saliva in the mouth using crystalline cellulose and a disintegrant. Biol. Pharm. Bull. 1995, 18 (9), 1308-1310.
8. Koizumi, K.; Watanabe, Y.; Morita, K.; Utoguchi, N.; Matsumoto, M. New method of preparing high porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material. Int. J. Pharm. 1997, 152 (1), 127-131. (Pubitemid 27254969)
9. Virley, P.; Yarwood, R. J. Zydis - a novel, fast dissolving dosage form. Manuf. Chem. 1990, 36, 36-37.
10. Ishikawa, T.; Watanabe, Y.; Utoguchi, N.; Matsumoto, M. Preparation and evaluation of tablets rapidly disintegrating in saliva containing bitter taste masked granules by the compression method. Chem. Pharm. Bull. 1999, 47 (10), 1451-1454. (Pubitemid 29510317)
11. Rajyaguru, T. H.; Indurwade, N. H.; Nahkhat, P. D. Novel approach - fast dissolving tablets. Indian Drugs 2002, 39 (8), 405-409.
12. Nadendla, R. R.; Sudhakar, G.; Srinath, N. Current status of dispersible dosage forms. Int. J. Pharma. Excip. 2002, 2, 25-28.
13. www.cpkelco.com
14. 3) A New Self-Lubricated, Easy to Swallow, Oral Dosage Form rev. 10/99, Kelco Biopolymers, pformulate/01/25/2004.
15. Sworn, G.; Kasapis, S. Effect of conformation and molecular weight of co-solute on the mechanical properties of gellan gum gels. Food Hydrocolloids 1998, 12 (3), 283-290.
16. Kelcogel® Gellan Gum: A Multifunctional Gelling Agent. San Diego: CP Kelco, www.cpkelco. com, accessed December 1, 2005.
17. Fialho, A. M.; Martins, L. O.; Donval, M. L.; Jorge, H. L.; Michael, J. R.; Andrew, J. J.; Victor, J. M.; Isabel, S. Structures and properties of gellan polymers produced by Sphingomonas paucimobilis ATCC 31461 from lactose compared with those produced from glucose and from cheese whey. Appl. Environ. Microbiol. 1999, 65 (6), 2485-2491.
18. Jansson, P. E.; Lindberg, B.; Sandford, P. A. Structural studies of gellan gum an extracellular polysaccharide elaborated by Pseudomonas elodea. Carbohydr. Res. 1983, 124 (1), 135-139.
19. Deasy, P. B.; Quigley, J. Rheological evaluation of deacylated gellan gum (Gelrite) for pharmaceutical use. Int. J. Pharm. 1991, 73 (2), 117-123.
20. Bayarri, S.; Rivas, I.; Costell, E.; Duran, L. Diffusion of sucrose and aspartame in kappa-carrageenan and gellan gum gels. Food Hydrocolloids 2001, 15 (1), 67-73. (Pubitemid 32172129)
21. Kelcogel® Gellan Gum: A Multifunctional Gelling Agent. San Diego: CP Kelco, www.cpkelco. com, accessed on December 1, 2005.
22. www.pformulate.com
23. Grasdalen, H.; Smidsrod, O. Gelation of gellan gum. Carbohydr. Polym. 1987, 7 (5), 371-393.
24. Nowak, D.; Antczak, A.; Król, M.; Bialasiewicz, P.; Pietras, T. Antioxidant properties of ambroxol. Free Radic. Biol. Med. 1994, 16 (4), 517-522. (Pubitemid 24106000)
25. Ericsson, C. H.; Juhasz, J.; Jöhnson, E.; Mossberg, B. Ambroxol and simple chronic bronchitis: effects on subjective symptoms and ventilatory function. Respiration 1987, 51 (Suppl 1), 33-36. (Pubitemid 17070799)
26. Guyatt, G. H.; Townsend, M.; Kazim, F.; Newhouse, M. T. A controlled trial of ambroxol in chronic bronchitis. Chest. 1987, 92 (4), 618-620. (Pubitemid 18000560)
27. Ratjen, F.; Wonne, R.; Posselt, H. G.; Stover, B.; Hofmann, D.; Bender, S. W. A double-blind placebo controlled trial with oral ambroxol and N-acetylcysteine for mucolytic treatment in cystic fibrosis. Eur. J. Pediatr. 1985, 144 (4), 374-378.
28. Vergin, H.; Bishop-Freundling, G. B.; Micka, M.; Nitsche, V.; Strobel, K.; Matzkies, F. Untersuchungen zur pharmakokinetik und bioaquivalenz unterschiedlicher darreichungs formenvon ambroxol. Arzneim-Forsch./Drug Res. 1985, 35, 1591-1595.
29. Basak, S. C.; Jayakumar Reddy, B. M.; Lucas Mani, K. P. Formulation and release behaviour of sustained release ambroxol hydrochloride HPMC matrix tablet. Indian J. Pharm. Sci. 2006, 68 (5), 594-598.
30. Grasdalen, H.; Smidsrod, O. Gelation of gellan gum. Carbohydr. Polym. 1987, 7 (5), 371-393.
31. Horinaka, J.; Kani, K.; Hori, Y.; Maeda, S. Effect of pH on the conformation of gellan chains in aqueous systems. Biophys. Chem. 2004, 111 (3), 223-227. (Pubitemid 39389140)
32. Rowe, R. C.; Sheshkey, P. J.; Weller, P. J. Handbook of Pharmaceutical Excepients, 4th ed.; Pharmaceutical Press: London, Chicago, 2003.
33. Camelin, I.; Lacroix, C.; Paquin, C.; Prevost, H.; Cachon, R.; Divies, C. Effect of chelatants on gellan gel rheological properties and setting temperature for immobilization of living bifidobacteria. Biotechnol. Prog. 1993, 9 (3), 291-297.
34. El-Kamel, A.; Al-Dosari, H.; Al-Jenoobi, F. Environmentally responsive ophthalmic gel formulation of carteolol hydrochloride. Drug Deliv. 2006, 13 (1), 55-59. (Pubitemid 43087621)
35. Sworn, G.; Kasapis, S. The use of Arrhenius and WLF kinetics to rationalize the mechanical spectrum in high sugar gellan system. Carbohydr. Res. 1998, 309, 353-361. (Pubitemid 29034649)
36. Pokharkar, V. B. Taste Masking of Pharmaceuticals, available at www.pharmainfo.net, accessed 2005.
37. Gaspar, C.; Laureano, O.; Sousa, I. Production of reduced-calorie grape juice jelly with gellan, xanthan and locust bean gums: sensory and objective analysis of texture. Z. Lebensm. Unters. Forsch A 1998, 206 (3), 169-174. (Pubitemid 128763289)
38. Mashimo, S.; Shinyashiki, N.; Matsumura, Y. Water structure in gellan gum-water system. Carbohydrate Polymers 1996, 30 (2-3), 141-144. (Pubitemid 126338596)