The effects of screw configuration and polymeric carriers on hot-melt extruded taste-masked formulations incorporated into orally disintegrating tablets

Journal of Pharmaceutical Sciences

Volumn 104, Issue 1, 2015, Pages 124-134

  Morott, Joseph T ^a   Pimparade, Manjeet ^a   Park, Jun Bom ^a   Worley, Chelsea P ^b   Majumdar, Soumyajit ^a   Lian, Zhuoyang ^c   Pinto, Elanor ^c   Bi, Yunxia ^c   Durig, Thomas ^c   Repka, Michael A ^a  

^a UNIVERSITY OF MISSISSIPPI   (United States)

^b The University of Mississippi   (United States)

^c ASHLAND INC   (United States)

Author keywords

Bitter API; Chemical imaging; Crystalline solid dispersion; Disintegrating tablets; Hot melt extrusion; Screw configuration; Taste masking

Indexed keywords

ETHYL CELLULOSE; SALIVA SUBSTITUTE; SILDENAFIL; ACETIC ACID DERIVATIVE; CELLULOSE; COPOLYVIDONUM PLASDONE S-630; DRUG CARRIER; EXCIPIENT; HYDROXYPROPYLCELLULOSE; PHOSPHODIESTERASE V INHIBITOR; PIPERAZINE DERIVATIVE; POLYMER; POVIDONE; PURINE DERIVATIVE; SULFONAMIDE; TABLET; VASODILATOR AGENT;

ARTICLE; DISSOLUTION; DRUG SOLUBILITY; HOT MELT EXTRUSION; IN VITRO STUDY; INFRARED SPECTROSCOPY; ORALLY DISINTEGRATING TABLET; PH; PHARMACEUTICS; PREFORMULATION; TABLET; TABLET FORMULATION; TABLET PROPERTY; ANALOGS AND DERIVATIVES; BIOLOGICAL MODEL; CHEMISTRY; COMPARATIVE STUDY; DEVICES; DRUG FORMULATION; EQUIPMENT DESIGN; HEAT; HUMAN; SALIVA; SOLUBILITY; STOMACH JUICE; SURFACE PROPERTY; TASTE;

ACETATES; CELLULOSE; DRUG CARRIERS; DRUG COMPOUNDING; EQUIPMENT DESIGN; EXCIPIENTS; GASTRIC JUICE; HOT TEMPERATURE; HUMANS; MODELS, BIOLOGICAL; PHOSPHODIESTERASE 5 INHIBITORS; PIPERAZINES; POLYMERS; POVIDONE; PURINES; SALIVA; SILDENAFIL CITRATE; SOLUBILITY; SULFONAMIDES; SURFACE PROPERTIES; TABLETS; TASTE; VASODILATOR AGENTS;

EID: 84919787885     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24262     Document Type: Article

References (23)

1. Ayenew Z, Puri V, Kumar L, Bansal A. 2009. Trends in Pharmaceutical Taste Masking Technologies: A Patent Review. Recent Patents on Drug Delivery & Formulation 3:26-39.
2. th ed. New York: Dekker, pp. 674-675.
3. Hirani J, Rathod D, Vadalia K. 2009. Orally Disintegrating Tablets: A Review. Trop J Pharm Res 161-172.
4. Egilius LH, Rapoport AM, Dodick DW, Charlesworth B. 2004. Acute Treatment of Migraine with Zolmitriptan 5 mg Orally Disintegrating Tablets. CNS Drugs 18(15):1133-1141.
5. Kinon BJ, Hill AL, Liu H, Kollack-Walker S. 2003. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia. Int J Neuropsychopharmacology 6(2):97-102.
6. Pahwa R, Pipiani M, Sharma PC, Kaushik D, Nanda S. 2010. Orally Disintegrating Tablets-Friendly to Pediatrics and Geriatrics. Archives of Applied Science Research 2(2):35-48.
7. Stange U, Führling C. 2014. Formulation, Preparation and Evaluation of Novel Orally Disintegrating Tablets Containing Taste-Masked Naproxen Sodium Granules and Naratriptan Hydrochloride. J Pharm Sci 103:1233-1245.
8. Strickley R, Iwata Q, Wu S, Dahl T. 2007. Pediatric drugs-a review of commercially available oral formulations. J Pharm Sci. 97:1731-1774.
9. Gupta M, Kovar A, Meibohm B. 2005. The Clinical Pharmacokinetics of Phosphodiesterase-5 Inhibitors for Erectile Dysfunction. J Clinical Pharmacology 45:987-1003.
10. ® (sildenafil citrate tablets) [package insert]. Pfizer, Inc. NY, NY. 1998.
11. ® (sildenafil citrate tablets) [package insert]. Pfizer, Inc. NY, NY. 2005.
12. Yi E, Kim J, Rhee Y, Kim S, Lee H, Park C. 2014. Preparation of sildenafil citrate microcapsules and in vitro/in vivo evaluation of taste masking efficiency. Int J Pharmaceutics 466:286-295.
13. Douroumis Dennis. 2014 A Review on the Taste Masking of Bitter APIs: Hot-Melt Extrusion (HME) Evaluation. Drug Dev And Ind Pharm Feb; 40(2):145-56.
14. Beers MH, Ouslander JG. 1989. Risk Factors in Geriatric Drug Prescribing, Drugs 37:105-112.
15. Repka MA, Thumma S, Upadhye S, Kumar S, McGinity J, Martin C. 2007. Pharmaceutical Applications of Hot Melt Extrusion: Part I Drug Dev and Ind Pharm 33:909-926.
16. Repka MA, Langley N, Di Nunzio J. 2013. Melt Extrusion, Materials, Technology and Drug Product Design. NY, Springer, 4-5; 14-16.
17. U. S. Food and Drug Administration. 2014. Alphabetical List of SCOGS Substances. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/SCOGS/ucm084104.htm
18. Repka MA, Shah S, Lu J, Maddineni S, Morott J, Padwardhan K, Mohammed N. 2012. Melt Extrusion: Process to Product. Expert Opinion on Drug Delivery 9:105-125.
19. Mannur VS, Rathi SM, Mastiholimath VS, Dengale NP, Shinde T A. 2011. Stability indicating RP-HPLC method development and validation of Sildenafil Citrate in pure form. Int J Res Pharm Sci 2:187-191.
20. Azarmi S, Roa W, Löbenberg R. 2007. Current perspectives in dissolution testing of conventional and novel dosage forms. Int J Pharmaceutics 328:12-21.
21. U. S. Food and Drug Administration. 2014. Dissolution Methods. http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp-Search Results-Dissolutions.cfm?PrintAll=1.
22. Melkinov P, Cobri P, Cuin A, Cavicchioli M, Guimareas W. 2003. Physicochemical properties of Sildenafil Citrate (Viagra) and Sildenafil Base. J Pharmaceutical Sciences 92:2140-2143.
23. Lu J, Rohani S. 2009. Polymorphism and crystallization of active pharmaceutical ingredients (APIs). Curr Med Chem 16:884-905.