Influence of non-water-soluble placebo pellets of different sizes on the characteristics of orally disintegrating tablets manufactured by freeze-drying

Journal of Pharmaceutical Sciences

Volumn 102, Issue 6, 2013, Pages 1786-1799

  Stange, Ulrike ^a   Führling, Christian ^b   Gieseler, Henning ^a,c  

^a UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^b Niederbronner Pharmacy   (Germany)

^c GILYOS GmbH   (Germany)

Author keywords

Excipients; Fast melting tablet; Formulation; Freeze drying; Lyophilization; Microparticles; Oral drug delivery; Orally disintegrating tablet

Indexed keywords

ALGINIC ACID; GELATIN; HETASTARCH; METHYLCELLULOSE; PLACEBO; SUCROSE;

ARTICLE; DRUG PELLET; FREEZE DRYING; TABLET DISINTEGRATION TIME; TABLET HARDNESS; TABLET MANUFACTURE;

EID: 84877920170     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23517     Document Type: Article

References (47)

1. Shukla D, Chakraborty S, Singh S, Mishra B. 2009. Mouth dissolving tablets. I: An overview of formulation technology. Sci Pharm 77(2):309-326.
2. Carnaby-Mann G, Crary M. 2005. Pill swallowing by adults with dysphagia. Arch Otolaryngol Head Neck Surg 131(11):970-975.
3. Gendolla A. 2005. Part I: What do patients really need and want from migraine treatment? Curr Med Res Opin 21:S3-S7.
4. Clarke A, Brewer F, Johnson ES, Mallard N, Hartig F, Taylor S, Corn TH. 2003. A new formulation of selegiline: Improved bioavailability and selectivity for MAO-B inhibition. J Neural Transm 110(11):1241-1255.
5. Corveleyn S, Paul Remon J. 1998. Bioavailability of hydrochlorothiazide: Conventional versus freeze-dried tablets. Int J Pharm 173(1-2):149-155.
6. Seager H. 1998. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol 50(4):375-382.
7. Shoukri RA, Ahmed IS, Shamma RN. 2009. In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets. Eur J Pharm Biopharm 73(1):162-171.
8. Ahmed IS, Hassan M. 2007. In vitro and in vivo evaluation of a fast-disintegrating lyophilized dry emulsion tablet containing griseofulvin. Eur J Pharm Sci 32(1):58-68.
9. Ahmed IS, Nafadi MM, Fatahalla FA. 2006. Formulation of a fast-dissolving ketoprofen tablet using freeze-drying in blisters technique. Drug Dev Ind Pharm 32(4):437-442.
10. Lai F, Pini E, Angioni G, Manca ML, Perricci J, Sinico C, Fadda AM. 2011. Nanocrystals as tool to improve piroxicam dissolution rate in novel orally disintegrating tablets. Eur J Pharm Biopharm 79(3):552-558.
11. Corveleyn S, Remon JP. 1997. Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug. Int J Pharm 152(2):215-225.
12. Jaccard TT, Leyder J. 1985. Lyoc-A new pharmaceutical form. Annales Pharmaceutiques Francaises 43(2):123-131.
13. Corveleyn S, Remon JP. 1998. Formulation of a lyophilized dry emulsion tablet for the delivery of poorly soluble drugs. Int J Pharm 166(1):65-74.
14. AlHusban F, Perrie Y, Mohammed AR. 2011. Formulation of multiparticulate systems as lyophilised orally disintegrating tablets. Eur J Pharm Biopharm 79(3):627-634.
15. AlHusban F, Perrie Y, Mohammed AR. 2010. Preparation, optimisation and characterisation of lyophilised rapid disintegrating tablets based on gelatin and saccharide. Curr Drug Deliv 7(1):65-75.
16. Chandrasekhar R, Hassan Z, AlHusban F, Smith AM, Mohammed AR. 2009. The role of formulation excipients in the development of lyophilised fast-disintegrating tablets. Eur J Pharm Biopharm 72(1):119-129.
17. Vennat B, Gross D, Pourrat A, Legret P. 1993. Oral freeze-dried forms of procyanidins. J Pharm Belg 48(6):430-436.
18. AlHusban F, Perrie Y, Mohammed AR. 2010. Formulation and characterisation of lyophilised rapid disintegrating tablets using amino acids as matrix forming agents. Eur J Pharm Biopharm 75(2):254-262.
19. AlHusban F, ElShaer AM, Kansara JH, Smith AM, Grover LM, Perrie Y, Mohammed AR. 2010. Investigation of formulation and process of lyophilised orally disintegrating tablet (ODT) using novel amino acid combination. Pharmaceutics 2:1-17.
20. Brown D. 2003. Orally disintegrating tablets-Taste over speed. Drug Deliv Technol 3(6):58-61
21. Sheshala R, Khan N, Darwis Y. 2011. Formulation and optimization of orally disintegrating tablets of sumatriptan succinate. Chem Pharm Bull 59(8):920-928.
22. Yan YD, Woo JS, Kang JH, Yong CS, Choi HG. 2010. Preparation and evaluation of taste-masked donepezil hydrochloride orally disintegrating tablets. Biol Pharm Bull 33(8):1364-1370.
23. Douroumis DD, Gryczke A, Schminke S. 2010. Development and evaluation of cetirizine HCl taste-masked oral disintegrating tablets. AAPS PharmSciTech 12(1):141-151.
24. Sugiura T, Uchida S, Namiki N. 2012. Taste-masking effect of physical and organoleptic methods on peppermint-scented orally disintegrating tablet of famotidine based on suspension spray-coating method. Chem Pharm Bull 60(3):315-319.
25. Haware RV, Chaudhari PD, Parakh SR, Bauer-Brandl A. 2008. Development of a melting tablet containing promethazine HCl against motion sickness. AAPS PharmSciTech 9(3):1006-1015.
26. Desobry SA, Netto FM, Labuza TP. 1997. Comparison of spray-drying, drum-drying and freeze-drying for β-carotene encapsulation and preservation. J Food Sci 62(6):1158-1162.
27. Patel SM, Jameel F, Pikal MJ. 2010. The effect of dryer load on freeze drying process design. J Pharm Sci 99(10):4363-4379.
28. Mohan N, Nair PD. 2005. Novel porous, polysaccharide scaffolds for tissue engineering applications. Trends Biomater Artif Organs 18(2):219-224.
29. Patel SM, Doen T, Pikal MJ. 2010. Determination of end point of primary drying in freeze-drying process control. AAPS PharmSciTech 11(1):73-84.
30. Tang XL, Pikal MJ. 2004. Design of freeze-drying processes for pharmaceuticals: Practical advice. Pharm Res 21(2):191-200.
31. Council of Europe. European Pharmacopoeia: supplement 7.1. 7th ed. Strasbourg: Council of Europe; 2007. Tablets, oral lyophilisates.
32. Scherer GW. 1993. Freezing gels. J Non-Cryst Solids 155(1):1-25.
33. Searles JA. 2010. Freezing and annealing phenomena in lyophilization. In Freeze drying/lyophilization of pharmaceutical and biological products; Rey L, May JC, Eds. New York: Informa Healthcare, pp 52-81.
34. Dawson PJ, Hockley DJ. 1992. Scanning electron microscopy of freeze-dried preparations: Relationship of morphology to freeze-drying parameters. Dev Biol Stand 74:185-192.
35. Kasper JC, Friess W. 2011. The freezing step in lyophilization: Physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm 78(2):248-263.
36. Zhang LJ, Liu L, Qian Y, Chen Y. 2008. The effects of cryoprotectants on the freeze-drying of ibuprofen-loaded solid lipid microparticles (SLM). Eur J Pharm Biopharm 69(2):750-759.
37. Shamblin SL. 2004. The role of water in physical transformations in freeze-dried product. In Lyophilization of biopharmaceuticals; Costantino HR, Pikal MJ, Eds. In: Borchard RT, Middaught CR, Series CR, editors. Biotechnology: Pharmaceutical aspects Vol. II:. Arlington, VA: AAPS Press, pp 229-270.
38. Shamblin SL, Huang EY, Zografi G. 1996. The effects of co-lyophilized polymeric additives on the glass transition temperature and crystallization of amorphous sucrose. J Therm Anal 47(5):1567-1579.
39. Pikal MJ, Shah S, Roy ML, Putman R. 1990. The secondary drying stage of freez-drying-Drying kinetics as a function of temperature and chamber pressure. Int J Pharm 60(3):203-217.
40. Sznitowska M, Placzek M, Klunder M. 2005. The physical characteristics of lyophilized tablets containing a model drug in different chemical forms and concentrations. Acta Pol Pharm 62(1):25-29.
41. U.S. Food and Drug Administration. 2008. Guidance for industry-Orally disintegrating tablets.
42. Council of Europe. European Pharmacopoeia. 7th ed. Strasbourg: Council of Europe; 2007.
43. Shukla D, Chakraborty S, Singh S, Mishra B. 2009. Mouth dissolving tablets. II: An overview of evaluation techniques. Sci Pharm 77(2):327-341.
44. Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier J, Piccerelle P. 2005. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int J Pharm 292(1-2):29-41.
45. Sunada H, Bi Y. 2002. Preparation, evaluation and optimization of rapidly disintegrating tablets. Powder Technol 122(2-3):188-198.
46. Mitchell JR. 1976. Rheology of gels. J Texture Stud 7(3):313-339.
47. Djaković LJ, Sovilj V, Milošević S. 1990. Rheological behaviour of thixotropic starch and gelatin gels. Starch-Stärke 42(10):380-385.