Design and Evaluation of Delayed-Release Osmotic Capsule of Acetaminophen Delayed-release osmotic capsule of acetaminophen
Iranian Journal of Pharmaceutical Sciences,
مجلد 2 عدد 2 (2006),
1 فروردین 2006
,
الصفحة 65-72
https://doi.org/10.22037/ijps.v2.39551
الملخص
Hard gelatin capsule filled with acetaminophen, osmotic agent (sorbitol), a release promoter (sodium dodecyl sulfate), coated with a semipermeable cellulose acetate membrane containing a hydrophobic plasticizer (castor oil) and sealed with white bees wax plug was designed. When placed in the sink water penetrates the membrane, dissolves the osmotic agent and increases the osmotic pressure inside the capsule. The increased osmotic pressure enhances the water imbibition and consequently increases the hydrostatic pressure inside the capsule and when the latter pressure is high enough it expels out the plug and the drug release commences. With cellulose acetate concentration constant in membrane forming solution, 11% (w/w), the factors affecting the onset of the drug release, i.e. the lag time (tL), were thickness of semipermeable membrane (0.033-0.112 mm) and plug thickness (2.40-3.40 mm) although the influence of semipermeable membrane thickness was more important than plug thickness in delaying the onset of release. As the statistical analysis revealed, castor oil concentrations in the range of 3-4% (w/w) did not affect the lag time. With the control of the membrane thickness, the onset of release could be adjusted from 2 to 7 h. The formulations with tL of 3.9 and 5.8 h may have practical benefits in that if such systems are administered simultaneously with conventional forms the 6 and 4 times daily drug dosage frequency would be reduced to 3 and 2 times regimens, respectively. A theoretical justification was provided for the observed nonlinear relationship between the onset and/or tL of drug release and thickness of the semipermeable membrane. After the lag time, the drug release from
the systems conformed to the USP requirements.
- Acetaminophen
- Cellulose acetate
- Delayed-release
- Onset of release
- Osmotic capsule
كيفية الاقتباس
المراجع
[2] Lemmer B. Circadian rhythms and delivery. J Control Rel 1991; 16: 63-74.
[3] Lemmer B. Chronopharmacokinetics: Implications for drug treatment. J Pharm Pharmacol 1999; 51: 887-90.
[4] Sangalli ME, Maroni A, Foppoli A, Zema L, Giordano F. Different HPMC viscosity grades as coating agents for an oral time and/or sitecontrolled delivery system: a study on process parameters and in vitro performances. Eur J Pharm Sci 2004; 22: 469-76.
[5] Chourasia MK, Jan SK. Pharmaceutical approaches to colon targeted drug delivery systems. J Pharm Pharm Sci 2003; 6: 33-66.
[6] Amidon GL, Leesman GD. Pulsatile drug delivery system. US Patent 5229131. July 20, 1993.
[7] Amidon GL, Leesman GD. Multi stage drug delivery system. US Patent 5387421. February 7, 1995.
[8] Conte U, Giunchedi P, Maggi L, Sangalli ME, Gazzaniga A. Ibuprofen delayed release dosage forms: A proposal for the preparation of an in vitro/ in vivo pulsatile system. Eur J Pharm Sci 1992; 38: 209-12.
[9] Gazzaniga A, Iamartino P, Maffione G, Sangalli ME. Oral delayed-release system for colonic specific delivery. Int J Pharm 1994; 108: 77-83.
[10] Wilding IR, Davis SS, Pozzi F, Furlani P, Gazzaniga A. Entric coated timed release systems for colonic targeting. Int J Pharm 1994; 111: 99-102.
[11] Krogel I, Bodmeier R. Floating or pulsatile drug delivery system based on coated effervescent cores. Int J Pharm 1999; 187: 175-84.
[12] Bussemer T, Dashevsky A, Bodmeier R. A pulsatile drug delivery system based on rupturable coated hard gelatin Capsules. J Control Rel 2003; 93: 337-9.
[13] Ueda Y, Hata T, Yamaguchi H, Ueda S, Kotani M. Time controlled explosion system and process for preparation for the system. US Patent 4871549, 1989.
[14] Schultz P, Kleinebudde P. A new multiparticulate delayed release system. Part I: Dissolution properties and release mechanism. J Control Rel 1997; 47: 181-9.
[15] Amsden B, Cheng YL. A generic protein delivery system based on osmotically rupturable monolits. J Control Rel 1995; 33: 99-105.
[16] Sangalli ME, Maroni A, Zerona L, Busetti C, Giordano F, Gazzaniga A. In vitro and in vivo evaluation of an oral system for time and/or sitespesific drug delivery. J Control Rel 2001; 73: 103-10.
[17] Wilding IR, Davis SS, Bakhshaee M, Stevens HNE, Sparrow RA, Brennan J. Gastrointestinal and systemic absorption of captopril from capsuled-release formulation. Pharm Res 1998; 9: 654-7.
[18] Krogel I, Bodmeier R. Pulsatile drug release from an insoluble capsule body controlled by an erodible plug. Pharm Res 1998; 15: 474-81.
[19] Chein YW. Novel drug delivery systems. New York: Marcel Dekker, 1992. [20] United states pharmacopoeia, USP28, Rockville: United States Pharmacopoeial Convension, 2005.
[21] Cardinal JR. Controlled release osmotic drug delivery systems for oral applications. In: Amidon GL, Lee PI, Topp EM (editors). Transport processes in pharmaceutical systems. New York: Marcel Dekker, 2000.
- الملخص المشاهدات: 102 الأوقات
- IJPS_Volume 2_Issue 2_Pages 65-72 (English) التنزيلات: 18 الأوقات