Understanding and managing the impact of HPMC variability on drug release from controlled release formulations

Journal of Pharmaceutical Sciences

Volumn 103, Issue 6, 2014, Pages 1664-1672

  Zhou, Deliang ^a   Law, Devalina ^a   Reynolds, Judie ^a   Davis, Lynn ^a   Smith, Clifford ^a   Torres, Jose L ^a   Dave, Viraj ^a   Gopinathan, Nishanth ^a   Hernandez, Daniel T ^a   Springman, Mary Kay ^a   Zhou, Casey Chun ^a  

^a ABBVIE INC   (United States)

Author keywords

controlled release; diffusion; dissolution; erosion; HPMC variability; hydrophilic matrices; NMR

Indexed keywords

HYDROXYPROPYLMETHYLCELLULOSE; NICOTINIC ACID; DELAYED RELEASE FORMULATION; TABLET;

CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DRUG DETERMINATION; DRUG POTENCY; DRUG RELEASE; DRUG SOLUBILITY; GELATION; HETERONUCLEAR MULTIPLE QUANTUM COHERENCE; HETERONUCLEAR SINGLE QUANTUM COHERENCE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROPHILICITY; MATRIX TABLET; MOLECULAR WEIGHT; PARTICLE SIZE; PHYSICAL CHEMISTRY; POTENTIAL DIFFERENCE; PROTON NUCLEAR MAGNETIC RESONANCE; REVIEW; SUBSTITUTION REACTION; TABLET COMPRESSION; VISCOSITY; CHEMICAL PHENOMENA; CHEMISTRY; DELAYED RELEASE FORMULATION; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; SOLUBILITY; TABLET;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DELAYED-ACTION PREPARATIONS; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; HYPROMELLOSE DERIVATIVES; MAGNETIC RESONANCE SPECTROSCOPY; SOLUBILITY; TABLETS;

EID: 84901257052     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23953     Document Type: Article

References (32)

1. Dow Chemicals Publication. 2000. Using methocel cellulose ethers for controlled release of drugs in hydrophilic matrix systems, The Dow Chemical Company, Midland, Michigan.
2. Dow Chemicals. 2002. Methocel cellulose ethers technical handbook, The Dow Chemical Company, Midland, Michigan.
3. Harland RS, Gazzaniga A, Sangalli ME, Colombo P, Peppas NA,. 1988. Drug/polymer matrix swelling and dissolution. Pharm Res 5: 488-494.
4. Lee PI, Peppas NA,. 1987. Prediction of polymer dissolution in swellable controlled-release systems. J Control Release 6: 207-215.
5. Ju TTC, Nixon PR, Pael MV,. 1995. Drug release from hydrophilic matrices. 1. New scaling laws for predicting polymer and drug release based on the polymer disentanglement concentration and the diffusion layer. J Pharm Sci 84: 1455-1463.
6. Gao P, Meury RH,. 1996. Swelling of hydroxypropyl methylcellulose matrix tablets. 1. Characterization of swelling using a novel optical imaging method. J Pharm Sci 85: 725-731.
7. Brown W, Johnsen RM,. 1981. Transport from an aqueous phase through cellulosic gels and membranes. J Appl Polym Sci 26: 4135-4148.
8. Lee PI., 1980. Diffusional release of a solute from a polymeric matrix-Approximate analytical solutions. J Membr Sci 7: 255-275.
9. Lee PI, Kim CJ,. 1991. Probing the mechanisms of drug release from hydrogels. J Control Release 16: 229-236.
10. Ritger PL, Peppas NA,. 1987. A simple equation for description of solute release. II. Fickian and anomalous release from swellable devices. J Control Release 5: 37-42.
11. Ritger PL, Peppas NA,. 1987. A simple equation for description of solute release. I. Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or disks. J Control Release 5: 23-36.
12. Klug ED,. 1971. Properties of water-soluble hydroxyalkyl celluloses and their derivatives. J Polym Sci Polym Symp 36: 491-508.
13. Sarkar N,. 1979. Thermal gelation properties of methyl and hydroxypropyl methylcellulose. J Appl Polym Sci 24: 1073-1087.
14. Gao P, Fagerness PE,. 1995. Diffusion in HPMC gels. I. Determination of drug and water diffusivity by pulsed-field-gradient spin-echo NMR. Pharm Res 12: 955-964.
15. Ju TTC, Nixon PR, Patel MV, Tong DM,. 1995. Drug release from hydrophilic matrices. 2. A mathematical model based on the polymer disentanglement concentration and the diffusion layer. J Pharm Sci 84: 1464-1477.
16. Dahl TC, Calderwood T, Bormeth A, Trimble K, Piepmeier E,. 1990. Influence of physicochemical properties of hydroxypropyl methyl cellulose on naproxen release from sustained release matrix tablets. J Control Release 14: 1-10.
17. Lucisano LJ, Breech JA, Angel LA, Franz RM,. 1989. Evaluation of an alternate source of hydroxypropyl methylcellulose for use in a substained-release tablet matrix. Pharm Tech 13: 88-98.
18. Bonferoni MC, Rossi S, Ferrari F, Bertoni M, Sinistri R, Carmella C,. 1995. Characterization of three hydroxypropyl methyl cellulose substitution types. Rheological properties and dissolution behavior. Eur J Pharm Biopharm 41: 242-246.
19. Reynolds TD, Gehrke SH, Hussain AS, Shenouda LS,. 1998. Polymer erosion and drug release characterization of hydroxypropyl hethylcellulose matrices. J Pharm Sci 87: 1115-1123.
20. Richardson S, Gorton L,. 2003. Characterisation of the substituent distribution in starch and cellulose derivatives. Anal Chim Acta 497: 27-65.
21. Viriden A, Wittgren B, Andersson T, Abrahmsen-Alami S, Larsson A,. 2009. Influence of substitution pattern on solution behavior of hydroxypropyl methylcellulose. Biomacromolecules 10: 522-529.
22. Viriden A, Wittgren B, Larsson A,. 2009. Investigation of critical polymer properties for polymer release and swelling of HPMC matrix tablets. Eur J Pharm Sci 36: 297-309.
23. Viridén A, Wittgren B, Andersson T, Larsson A,. 2009. The effect of chemical heterogeneity of HPMC on polymer release from matrix tablets. Eur J Pharm Sci 36: 392-400.
24. Desai D, Rinaldi F, Kothari S, Paruchuri S, Li D, Lai M, Fung S, Both D,. 2006. Effect of hydroxypropyl cellulose (HPC) on dissolution rate of hydrochlorothiazide tablets. Int J Pharm 308: 40-45.
25. O'Sullivan AC., 1997. Cellulose: The structure slowly unravels. Cellulose 4: 173-207.
26. Mischnick P., 1997. New developments in the analysis of the substitution pattern of polysaccharide derivatives. Macromol Symp 120: 281-290.
27. Mischnick P., 2001. Challenges in structure analysis of polysaccharide derivatives. Cellulose (Dordrecht, Netherlands) 8: 245-257.
28. Fitzpatrick F, Schagerloef H, Andersson T, Richardson S, Tjerneld F, Wahlund K-G, Wittgren B,. 2006. NMR, cloud-Point measurements and enzymatic depolymerization: Complementary tools to investigate substituent patterns in modified celluloses. Biomacromolecules 7: 2909-2917.
29. Viriden A, Larsson A, Schagerloef H, Wittgren B,. 2010. Model drug release from matrix tablets composed of HPMC with different substituent heterogeneity. Int J Pharm 401: 60-67.
30. Bettini R, Catellani PL, Santi P, Massimo G, Peppas NA, Colombo P,. 2001. Translocation of drug particles in HPMC matrix gel layer: Effect of drug solubility and influence on release rate. J Control Release 70: 383-391.
31. Colombo P, Bettini R, Santi P, De Ascentiis A, Peppas NA,. 1996. Analysis of the swelling and release mechanisms from drug delivery systems with emphasis on drug solubility and water transport. J Control Release 39: 231-237.
32. Pham AT, Lee PI,. 1994. Probing the mechanisms of drug release from hydroxypropyl methyl cellulose matrixes. Pharm Res 11: 1379-1384.