Influence of hydroxypropyl methylcellulose polymer on in vitro and in vivo performance of controlled release tablets containing alprazolam

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 56, Issue 3, 2003, Pages 461-468

  Mahaguna, Vorapann ^a,e   Talbert, Robert L ^a,b   Peters, Jay I ^b   Adams, Sandra ^b   Reynolds, Thomas D ^c,f   Lam, Francis Y W ^b   Williams III, Robert O ^a,d  

^a The Center for Molecular Carcinogenesis and Toxicology   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c DOW CHEMICAL COMPANY   (United States)

^d UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^e LLC   (United States)

^f PFIZER INC   (United States)

Author keywords

Alprazolam; Bioequivalence; Hydroxypropyl methylcellulose; Molecular weight; Pharmacodynamics; Pharmacokinetics

Indexed keywords

ALPRAZOLAM; HYDROXYPROPYLMETHYLCELLULOSE; POLYMER;

ADULT; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG MONITORING; DRUG SCREENING; DRUG SOLUBILITY; FEEDING; FEMALE; HUMAN; HUMAN EXPERIMENT; HUMIDITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MOLECULAR WEIGHT; NORMAL HUMAN; PATIENT; PERFORMANCE; PREDICTION; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEDATION; TABLET FORMULATION; TEMPERATURE; TIME; VISUAL ANALOG SCALE; WAKEFULNESS;

EID: 0242269020     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0939-6411(03)00116-4     Document Type: Article

References (29)

1. Alderman D.A. A review of cellulose ethers in hydrophilic matrices for oral controlled-release dosage forms. Int. J. Pharm. Tech. Prod. Mfg. 5:1984;1-9.
2. Helena Amaral M., Sousa Lobo J.M., Ferreira D.C. Effect of hydroxypropyl methylcellulose and hydrogenated castor oil on naproxen release from sustained-release tablets. AAPS Pharm. Sci. Tech. 2:2001;1-8.
3. Ford J.L., Rubinstein M.H., Hogan J.E. Formulation of sustained release promethazine hydrochloride tablets using hydroxypropylmethylcellulose matrices. Int. J. Pharm. 24:1985;327-338.
4. Cheong L.W.S., Heng P.W.S., Wong L.F. Relationship between polymer viscosity and drug release from a matrix system. Pharm. Res. 9:1992;1510-1514.
5. Tahara K., Yamamoto K., Nishihata T. Overall mechanism behind matrix sustained release (SR) tablets prepared with hydroxypropyl methylcellulose 2910. J. Controlled Release. 35:1995;59-66.
6. Krogel I., Bodmeier R. Development of a multifunctional matrix drug delivery system surrounded by an impermeable cylinder. J. Controlled Release. 61:1999;43-50.
7. Shah N., Zhang G., Apelian V., Zeng F., Infield M.H., Malick A.W. Prediction of drug release from hydroxypropyl methylcellulose (HPMC) matrices: effect of polymer concentration. Pharm. Res. 10:1993;1693-1695.
8. Xu G., Sunada H. Influence of formulation change on drug release kinetics from hydroxypropylmethylcellulose matrix tablets. Chem. Pharm. Bull. 43:1995;483-487.
9. Velasco M.V., Ford J.L., Rowe P., Rajabi-Siahboomi A.R. Influence of drug: hydroxypropylmethylcellulose ratio, drug and polymer particle size and compression force on the release of diclofenac sodium from HPMC tablets. J. Controlled Release. 57:1999;75-85.
10. Mitchell K., Ford J.L., Armstrong D.J., Elliot P.N.C., Hogan J.E., Rostron C. The influence of substitution type on the performance of methyl cellulose and hydroxypropylmethylcellulose in gels and matrices. Int. J. Pharm. 100:1993;143-154.
11. Brown J., Madit N., Cole E.T., Wilding I.R., Cade D. The effect of cross-linking on the in-vivo disintegration of hard gelatin capsules. Proc. 2nd World Meeting AGPI/APV, Paris. 25/28:1998;163-164.
12. Hardy J.G., Davis S.S., Wilson C.G. Drug Delivery to the Gastrointestinal Tract. 1989;Ellis Horwood, Chichester, UK.
13. Davis S.S., Khosla R., Wilson C.G., Washington N., Leslie S.T., Malkowska S. The gastrointestina transit of a controlled release formulation of indomethacin. Int. J. Pharm. 60:1990;191-196.
14. Williams L., Davis J.A., D J.A., Lowenthal T. The influence of food on the absorption and metabolism of drugs. Clin. Nutr. 77:1993;815-829.
15. McLachlan A.J., Tett S.E., Cutler D.J., Day R.O. Absorption and in vivo dissolution of hydroxychloroquine in fed subjects assessed using deconvolution techniques. Br. J. Clin. Pharm. 36:1993;405-411.
16. Borin M.T., Forbes K.K., Hughes G.S. The bioavailability of cefpodoxime proxetil tablets relative to an oral solution. Biopharm. Drug Dispos. 16:1995;295-302.
17. Paintaud G., Alvan G., Eckernas S.A., Wakelkamp M., Grahnen A. The influence of food intake on the effect of two controlled release formulations of furosemide. Biopharm. Drug Dispos. 16:1995;221-232.
18. DeVane J.G., Kelly J.G., Geoghegan B. Pharmacokinetic and in-vitro characteristics of sustained release verapamil products. Drug Dev. Ind. Pharm. 16:1990;1223-1248.
19. Kenyon C.J., Hooper G., Tierney D., Butler J., DeVane J., Wilding I.R. The effect of food on the gastrointestinal transit and systemic absorption of a naproxen from a novel sustained release formulation. J. Controlled Release. 34:1995;31-36.
20. Greenblatt D.J., Arendt R.M., Abernethy D.R., Giles H.G., Sellers E.M., Shader R.I. In vitro quantitation of benzodiazepine lipophilicity: relation to in vivo distribution. Br. J. Anaesth. 55:1983;985-989.
21. Garzone P.D., Kroboth P.D. Pharmacokinetics of the newer benzodiazepines. Clin. Pharmacokin. 16:1989;337-364.
22. Laihanen N., Muttonen E., Laaksonen M. Solubility and intrinsic dissolution rate of alprazolam crystal modifications. Pharm. Dev. Technol. 1:1996;373-380.
23. Laihanen N., Yliruusi J. Physical stability of alprazolam dihydrate: intact, ground and tabletted samples compatibility with certain commonly used tabletting excipients. S.T.P. Pharm. Sci. 6:1996;403-409.
24. Williams R.O. III, Sykora M.A., Mahaguna V. Method to recover a lipophilic drug from hydroxypropyl methylcellulose matrix tablets. AAPS Pharm. Sci. Tech. 2:2001;1-9.
25. Acikkol M., Barlaa B.D., Rollas S. High performance liquid chromatographic and UV spectrophotometric analysis of alprazolam. Pharmazie. 46:1991;461-462.
26. Moore J.W., Flanner H.H. Mathematical comparison of curves with an emphasis on in intro dissolution profiles. Pharm. Technol. 20:1996;64-74.
27. Abdou H.M. Dissolution, Bioavailability and Bioequivalence. 1989;Mack Publishing, Easton, PA.
28. Greenblatt D.J., Wright C.E. Clinical pharmacokinetics of alprazolam. Clin. Pharmacokin. 24:1993;453-471.
29. Charman W.N. Lipids, lipophilic drugs, and oral drug delivery - some emerging concepts. J. Pharm. Sci. 89:2000;967-978.