APPROACHES TO ACHIEVE AN ORAL CONTROLLED RELEASE DRUG DELIVERY SYSTEM USING POLYMERS: A RECENT REVIEW
Keywords:
Controlled release drug delivery system, Matrix system, Polymer, GelucireAbstract
The present article contains a brief review of various formulation approaches used in controlled release drug delivery systems, the role of polymers in the controlled delivery of many fast release drugs and the mechanism of drug release from these polymeric matrices. The oral controlled release system of many drugs has been known to be an essential part of formulation development in drug delivery systems. It has been the focus of pharmaceutical research for many years due to its various advantages over conventional dosage forms. Administering the drug for release in the blood at a controlled rate, to maintain relatively constant drug levels in plasma over a controlled period of time, can overcome many problems associated with conventional dosage forms. The applicability of these dosage forms is due to reduction in the frequencies of drug dosing, which lead to patient convenience and compliance. In addition, a reduction of wide fluctuations in plasma drug concentration peak can be obtained. As a result, toxicity and poor efficacy can be avoided, especially with drugs of narrow therapeutic indices. Such problems, associated with conventional dosage forms of many drugs, can be overcome by using controlled release drug delivery systems, to deliver the drug for absorption at a controlled rate over an extended period of time. The controlled release dosage form should be tailored so that variations in the components can lead to predictable alterations in the drug release profiles. Various controlled release drug delivery systems have different mechanisms to control the drug release rate, such as the osmotic pump, ion exchange resin and matrix systems which have been widely utilized as controlled release drug delivery approaches. Besides, polymers have often been used in the components of controlled release drug delivery systems. A sustained release profile, without occurring of the dose dumping, and sufficient bioavailability can be achieved when a drug is embedded in some polymeric materials such as gelucires.
Â
Downloads
References
Patel KK, Patel MS, Bhatt NM, Patel LD, Pathak NL, Patel KJ. An overview: extended release matrix technology. Int J Pharm Chem Sci 2012;1(2):828-43.
Sanap SL, Savkare AD. Controlled porosity osmotic pump: a review. Int J Pharm Res Dev 2014;5(12):70-80.
Gahlyan M, Jain S. Oral controlled release drug delivery system-a review. Pharmatutor 2014;2(8):170-8.
Kumar S, Kumar A, Gupta V, Malodia K, Rakha P. Oral extended release drug delivery system: a promising approach. Asian J Pharm Tech 2012;2(2):38-43.
Kumar S, Kumar H, Kumar R, Kumar A, Malodia K. Design, development and characterization of salbutamol sulphate extended release matrix tablets. Res J Pharm Biol Chem Sci 2013;4(3):270-7.
Keraliya RA, Patel C, Patel P, Keraliya V, Soni TG, Patel RC, et al. Osmotic drug delivery system as a part of modified release dosage form. ISRN Pharm 2012;2012:1-9.
Pandita A, Sharma P. Pharmacosomes: an emerging novel vesicular drug delivery system for poorly soluble synthetic and herbal drugs. ISRN Pharm 2013;2013:1-10.
Khirwadkar P, Singh D, Dashora K. Microchip technology: a new approach in novel drug delivery system. IJBAR 2012;3(3):149-61.
Dixit N, Maurya SD, Sagar BPS. Sustained release drug delivery system. Indian J Res Pharm Biotech 2013;1(3):305-10.
Kotha R, Raghavapally SG, Adavi SL, Taranali S, Pandey D. Current techniques in pulsatile drug delivery: a review. Int Res J Pharm 2013;4(3):77-84.
Arafat M, Golocorbin-Kon S, Mikov M. The measurement of cefotaxime sodium in rat plasma after oral administration: a sensitive HPLC-UV method. Int J Pharm Pharm Sci 2015;7(4):343-6.
Moodley K, Pillay V, Choonara YE, du Toit LC, Ndesendo VMK, Kumar P, et al. Oral drug delivery systems comprising altered geometric configurations for controlled drug delivery. Int J Mol Sci 2013;13(1):18-43.
Narasimharao R, Anusha RM, Swetha RN, Divyasagar P, Keerthana K. Design and evaluation of metformin hydrochloride extended release tablets by direct compression. Int J Res Pharm Biomed Sci 2011;2(3):1118-33.
Kumar KPS, Bhowmik D, Dutta A, Paswan S, Deb L. Recent trends in scope and opportunities of control release oral drug delivery systems. Crit Rev Pharm Sci 2012;1:20-33.
Nokhodchi A, Raja S, Patel P, Asare-Addo K. The role of oral controlled release matrix tablets in drug delivery systems. Bioimpacts 2012;2(4):175-87.
Pundir S, Badola A, Sharma D. Sustained release matrix technology and recent advance in matrix drug delivery system: a review. Int J Drug Res Tech 2013;3(1):12-20.
Rao NGR, Sounya P, Revathi K, Nayak BS. A review on pulastile drug delivery system. Int Res J Pharm 2013;4(3):31-44.
Rathore AS, Jat RC, Sharma N, Tiwari R. An overview: matrix tablet as controlled drug delivery system. Int J Res Dev Pharm Life Sci 2013;2(4):482-92.
Jaimini M, Kothari AH. Sustained release matrix type drug delivery system: a review. J Drug Delivery Ther 2012;2(6):142-8.
Rancan F, Blume-Peytavi U, Vogt A. Utilization of biodegradable polymeric materials as delivery agents in dermatology. Clin Cosmet Invest Dermatol 2014;7:23-34.
Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical Dosage Forms: Tablets. 2nd ed. New York/Basel: Marcel Dekker; 1990. p. 195-246.
Gren T, Bjerre C, Camber O, Ragnarsson G. In vitro drug release from porous cellulose matrices. Int J Pharm 1996;141(1-2):53-62.
Efentakis M, Peponaki C. Formulation study and evaluation of matrix and three-layer tablet sustained drug delivery systems based on carbopols with isosorbitemononitrate. AAPS Pharm Sci Tech 2008;9(3):917-23.
Syed IA, Mangamoori LN, Rao YM. Formulation and characterization of matrix and triple-layer matrix tablets for controlled delivery of metoprolol tartrate. Int J Pharm Sci Drug Res 2011;3(1):23-8.
Sathiyaraj S, Devi RD, Hari VBN. Lornoxicam gastro retentive floating matrix tablets: Design and in vitro evaluation. J Adv Pharm Technol Res 2011;2(3):156-62.
Gambhire MN, Ambade KW, Kurmi SD, Kadam VJ, Jadhav KR. Development and in vitro evaluation of an oral floating matrix tablet formulation of diltiazem hydrochloride. AAPS Pharm Sci Tech 2007;8(3):1-9.
Arafat M. Simple HPLC validated method for the determination of diltiazem hydrochloride in human plasma. Int J Pharm Pharm Sci 2014;6(9):213-6.
Balamuralidhara V, Pramodkumar TM, Srujana N, Venkatesh MP, Gupta NV, Krishna KL, et al. pH sensitive drug delivery systems: a review. Am J Drug Discovery Dev 2011;1(1):24-48.
Arora G, Malik K, Singh I, Arora S, Rana V. Formulation and evaluation of controlled release matrix mucoadhesive tablets of domperidone using saliva plebeian gum. J Adv Pharm Technol Res 2011;2(3):163-9.
Mishra B, Sankar C, Dilip C, Pravitha V, Raj A, Sadique TA. Osmotically controlled diclofenac sodium tablets: membrane and osmogens effects. Pharm Lett 2010;2(6):21-7.
Babu CA, Rao MP, Vijaya RJ. Controlled-porosity osmotic pump tablets-An overview. J Pharm Res Health Care 2010;2(1):114-26.
Herrlicha S, Spietha S, Messnera S, Zengerle R. Osmotic micropumps for drug delivery. Adv Drug Delivery Rev 2012;64(14):1617-27.
Prabakaran D, Singh P, Kanaujia P, Vyas SP. Effect of hydrophilic polymers on the release of diltiazem hydrochloride from elementary osmotic pump. Int J Pharm 2003;259(1-2):173-9.
Imran K, Priyanka A, Deepti R, Fiza F. A review: an article of importance in its field of osmotic pump CDD. Indo Am J Pharm Res 2013;3(4):3147-57.
Singh PL, Sihorkar V, Mishra V, Saravanababu B, Venkatatan N, Vyas SP. Osmotic pumps: from present view to newer perspectives in pharmaceutical industry. East Pharm 1999;502:39-46.
Singh K, Walia MK, Agarwal G, Harikumar SL. Osmotic pump drug delivery system: a novel approach. J Drug Delivery Ther 2013;3(5):156-62.
Swanson DR, Barclay BL, Wong PSL, Theeuwes F. Nifedipine gastrointestinal therapeutic system. Am J Med 1987;83:3-9.
Chung M, Reitberg DP, Gaffney M, Singleton W. Clinical pharmacokinetics of nifedipine gastrointestinal therapeutic system. Am J Med 1987;83:10-4.
Godbillon J, Gereedin A, Richard J, Leroy D, Mopprt J. Osmotically controlled delivery of metoprolol in man: in vivo performance of oros systems with different duration of drug release. Br J Clin Pharmacol 1985;19(2):213-8.
Bradbrook ID, John VA, Morrison PJ, Rogers HJ, spector RG. Pharmacokinetic investigation of the absorption of oxprenolol from oros delivery systems in healthy volunteers: comparison of inï€vivo and inï€vitro drug release. Br J Clin Pharmacol 1985;19(2):163-9.
Ozdemir N, Sahin J. Design of a controlled release osmotic pump system of ibuprofen. Int J Pharm 1997;158(1):91-7.
Ramakrishna N, Mishra B. Design and evaluation of osmotic pump tablets of naproxen sodium. Pharmazie 2001;56(12):958-62.
Patel KN, Metha TA. A review on oral osmotically driven system. Int J Pharm Pharm Sci 2013;5(3):1005-13.
Gupta BP, Thakur N, Jain NP, Banweer J, Jain S. Osmotically controlled drug delivery system with associated drugs. J Pharm Pharm Sci 2010;13(4):571-88.
Patra CN, Swain S, Sruti J, Patro AP, Panigrahi KC, Beg S, et al. Osmotic drug delivery systems: basics and design approaches. Recent Pat Drug Delivery Formulation 2013;7(2):150-61.
Shivanand P, Devmurari V. Formulation and evaluation of osmotic pumps: an overview. Pharm Lett 2010;2(1):189-95.
Gupta S, Singh RP, Sharma R, Kalyanwat R, Lokwani P. Osmotic pump: a review. IJCP 2011;2(6):1-8.
Bilandi A, Mishra AK. Ion exchange resins: an approach towards taste masking of bitter drugs and sustained release formulations with their patents. Int Res J Pharm 2013;4(8):65-74.
Alexandratos SD. Ion-exchange resins: a retrospective from industrial and engineering chemistry research. Ind Eng Chem Res 2009;48(1):388-98.
Sharma V, Chauhan CS. Ion exchange resins and their applications. J Drug Delivery Ther 2014;4(4):115-23.
Sharma V, Singh L. Ion exchange resins: a boon for pharmaceutical industry–an overview. Int J Pharm Sci Rev Res 2011;6(1):10-3.
Mahore JG, Wadher KJ, Umekar MJ, Bhoyar PK. Ion exchange resins: pharmaceutical applications and recent advancement. Int J Pharm Sci Rev Res 2010;1(2):8-13.
Pande SV, Kshirsagar MD, Chandewar AV. Ion exchange resins pharmaceutical applications and recent advancement. Int J Adv Pharm Sci 2011;2(1):8-16.
Grass GM, Robinson JR. Sustained and controlled release drug delivery systems. In: Gilbert S, Banker, Christopher T. editors. 4th ed. Wisconsin: CRC Press; 2002. p. 357-71.
Levina M, Rajabi-Siahboomi AR. The influence of excipients on drug release from hydroxypropyl methylcellulose matrices. J Pharm Sci 2004;93(11):2746-54.
Gawali P, Gupta A, Kachare S, Kshirsagar S. Formulation and evaluation of matrix-based sustained release tablets of quetiapinefumarate and the influence of excipients on drug release. J Chem Pharm Res 2012;4(6):3073-81.
Huichao W, Shouying D, Yang L, Ying L, Di W. The application of biomedical polymer material hydroxy propyl methyl cellulose (HPMC) in pharmaceutical preparations. J Chem Pharm Res 2014;6(5):155-60.
Kola R, Kumar BP. A detailed description of synthetic and natural polymers which are used in the formulation of sustained release drug delivery system: a review. JCPS 2013;6(3):161-9.
Yousif E, Haddad R. Photodegradation and photostabilization of polymers, especially polystyrene: review. SpringerPlus 2013;2:398.
Craig DQM. The use of glycerides as controlled release matrices. In: Excipients and delivery systems for pharmaceutical formulations London: The Royal Society of Chemistry; 1995. p. 148-71.
Da Fonseca Aab, De Geest BG, Vervaet C, Remon JP. Gelucire 44/14 based immediate release formulations for poorly water-soluble drugs. Drug Dev Ind Pharm 2013;39(5):791-8.
Upadhyay P, Pandit JK, Wahi AK. Gelucire: an alternative formulation technological tool for both sustained and fast release of drugs in treating diabetes mellitus type II disease. J Sci Ind Res 2013;72:776-80.
Huet de Barochez B, Lapeyer F, Cuine A. Oral sustained release dosage forms. Comparison between matrices and reservoir devices. Drug Dev Ind Pharm 1989;15:1001-20.
Vilaï€Jato JL, Delgado B. Possible use of Gelucire in controlled nifedipine tablets. STP Pharma 1990a;6:88-92.
Vilaï€Jato JL, Delgado B. Influence of melting point and HLB on the release of amoxycilline from granulates containing Gelucire as excipients. STP Pharma 1990b; 6:287-91.
Serajuddin ATM, Sheen PC, Mufson D, Bernstein DF, Augustine MA. Effect of amphiphilicity on the dissolution and bioavailability of a poorly water soluble drug from solid dispersions. J Pharm Sci 1988;77(5):414-7.
Smith A, Lampard JF, Carruthers KM, Regan P. The filing of molten ibuprofen into hard gelatin capsules. Int J Pharm 1990;59:115-9.
Ortigosa C, Gaudy D, Jacob M, Puech A. The role of gelucire in the availability of theophylline in semiï€solid matrix capsules. A study of factors: pH, melting point, HLB and paddle rotation speed. Pharm Acta Helv 1991;66:311-5.
Damian F, Blaton N, Naesens L, Balzarini J, Kinget R, Augustijns P, et al. Physicochemical characterization of solid dispersions of the antiviral agent UC-781 with polyethylene glycol 6000 and Gelucire 44/14. Eur J Pharm Sci 2000;10(4):311-22.
Damian F, Blaton N, Kinget R, Van den MG. Physical stability of solid dispersions of the antiviral agent UCï€781 with PEG 6000, Gelucire 44/14 and PVP K30. Int J Pharm 2002;244(1-2):87-98.
Khoo KC, Gibaldi M, Brazzell RK. Comparison of statistical moment parameters to Cmax and Tmax for detecting differences in an inï€vitro dissolution rates. J Pharm Sci 1985;74:1340-2.
Bruce JA, Nhung HN, Nancy JR, Susan MR, Munir AH, Susan JW, et al. Amphiphilic vehicles improve the oral bioavailability of a poorly soluble HIV protease inhibitor at high doses. Int J Pharm 1997;156(1):79-88.
Sutananta W, Crig DQ, Newton JM. An evaluation of the mechanism of drug release from glyceride bases. Int J Pharm 1995;47(3):182-7.
Green JT, Evans BK, Rhodes J, Thomas GA, Ranshaw C, Feyerabend C, et al. An oral formulation of nicotinic for release and absorbtion in the colon: its development and pharmacokinetics. Br J Clin Pharmacol 1999;48(4):485-93.
Remuñán C, Bretal MJ, Nunez A, Vila Jato JL. Accelerated stability study of sustainedï€release nifidepine tablets prepared with Gelucire®. Int J Pharm 1992;80:151-9.
Serajuddin AT. Solid dispersion of a poorly waterï€soluble drug: Early Promises, Subsequent problems, and recent breakthroughs. J Pharm Sci 1999;88(10):1058-66.
Esquisabel A, San Vicenete A, Igartua M, Hernandez RM, Gascon AR, Calvo MB, et al. Influence of melting point and hydrophilic/lipophilic balance on the release of salbutamol sulfate from lipid matrices. STP Pharm Sci 1996;6(5):365-9.
Baykara T, Yuksel N. The preparation of prolonged action formulations in the form of semi solid matrix into hard gelatin capsules of oxprenolol I. Thermocap method. Drug Dev Ind Pharm 1991;17:1215-27.
Vialï€Bernasconi AC, Doelker E, Buri P. Diffusion and erosion controlled drug release from lipid matrix formulations incorporated into hard gelatin capsules. Proc Int Symp Controlled Release Bioact Mater 1987;12:272-3.
Doelker C, Doelker E, Buri P, Waginaire L. The incorporation and in vitro release profiles of deliquescent or unstable drug with fusible excipients in hard gelatin capsules. Drug Dev Ind Pharm 1986;12:1553-65.
Saraiya D, Bolton S. The use of Precirol to prepare sustained release tablets of theophylline and quinidine gluconate. Drug Dev Ind Pherm 1990;16:1963-9.
Magron P, Rollet M, Taverdet JL, Vergnaud JM. Spherical oral polymer drug device with two polymers for constant drug delivery. Int J Pharm 1987;38:91-7.
Laghoueg N, Paulet J, Taverdet JL, Vergnaud JM. Oral polymerï€drug device with a core and erodible shell for constant drug delivery. Int J Pharm 1989;50(2):133-9.
Bidah D, Vergnaud JM. Kinetics if in vitro release of sodium salicylate dispersed in Gelucire. Int J Pharm 1990;58:215-20.
Bidah D, Vergnaud JM. New oral dosage forms with two polymers: Gelucire and Sumikgel. Int J Pharm 1991;72:35-41.
Bodmeier R, Paeratakul O, Chen H, Zhang W. Formulation of sustained release wax matrices within hard gelatin capsules in a fluidized bed. Drug Dev Ind Pharm 1990;16:1505-19.