Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Annas Binarjo; Husnul Khotimah

doi:10.15416/ijpst.v4i1.7933

Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Annas Binarjo, Husnul Khotimah

Abstrak

Kelarutan piroksikam yang rendah mempengaruhi laju disolusi sebagai penentu bioavaibilitas. Pembuatan dispersi padat dengan piroksikam-polietilenglikol dapan meningkatkan laju disolusinya. Tujuan penelitian ini adalah untuk mengetahui pengaruh pembentukan dispersi padat piroksikam- polietilenglikol 6000 (PEG 6000) terhadap laju disolusi kapsul piroksikam selama 1 bulan penyimpanan. Rekristal piroksikam (R) dan dispersi padat piroksikam-PEG 6000 (DP) dibuat dengan metode pelarut menggunakan campuan aseton-etanol (1:1), keduanya bersama dengan piroksikam tanpa modifikasi (P) dikapsul dan disimpan selama 1 bulan. Uji disolusi dilakukan setiap minggu. Efisiensi disolusi 60 menit (DE60), prosentase disolusi 45 menit (C45), dan waktu untuk 80% terdisolusi (t80) digunakan sebagai parameter disolusi. Kurva hubungan DE60, C45, dan t80 terhadap waktu penyimpanan dilihat slope-nya sebagai parameter stabilitas. Hasil percobaan menunjukkan bahwa Kapsul P dan DP menunjukkannilai DE60, C45, dan t80 yang stabil selama penyimpanan (slope=0, p>0.05), demikian juga nilai t80 kapsul R. Sedangkan DE60 dan C45 kapsul R selama penyimpanan terus menurun dengan slope -0,636 %/hari dan -0,171 mg/hari. Dapat disimpulkan bahwa DP yang dibuat dengan metode pelarut campuran aseton dan etanol (1:1) menunjukkan profil disolusi yang stabil selama penyimpanan 1 bulan.

Teks Lengkap:

PDF

Referensi

Sanka K, Munjulury VS, Mohd AB, Diwan PV. Enhancement of solubility, dissolution release profile and reduction in ulcerogenicity of piroxicam by inclusion complex with skimmed milk. Drug Deliv. 2014 Nov;21(7):560–70.

Dixit M, Kulkarni PK. Lyophilization monophase solution technique for improvement of the solubility and dissolution of piroxicam. Res Pharm Sci. 2012 Jan;7(1):13–21.

Savjani KT, Gajjar AK, Savjani JK. Drug Solubility: Importance and Enhancement Techniques. ISRN Pharm. 2012 Jul 5;2012:1–10.

Shah TJ, Amin AF, Parikh JR, Parikh RH. Process optimization and characterization of poloxamer solid dispersions of a poorly water-soluble drug. AAPS PharmSciTech. 2007 Jun;8(2):E18–24.

Dixit M, Kini AG, Kulkarni PK. Preparation and characterization of microparticles of piroxicam by spray drying and spray chilling methods. Res Pharm Sci. 2010;5(2):89–97.

Kumpugdee-Vollrath M, Ibold Y. Increasing Solubility of Poorly Water Soluble Drug Resveratrol by Surfactants and Cyclodextrins. Adv Mater Res. 2011 Dec;418–420:2231–4.

Huang Y, Dai W-G. Fundamental aspects of solid dispersion technology for poorly soluble drugs. Acta Pharm Sin B. 2014 Feb;4(1):18–25.

Bouchal F, Skiba M, Chaffai N, Hallouard F, Fatmi S, Lahiani-Skiba M. Fast dissolving cyclodextrin complex of piroxicam in solid dispersion part I: influence of β-CD and HPβ-CD on the dissolution rate of piroxicam. Int J Pharm. 2015 Jan 30;478(2):625–32.

Valizadeh H, Zakeri-Milani P, Barzegar-Jalali M, Mohammadi G, Danesh-Bahreini M-A, Adibkia K, et al. Preparation and characterization of solid dispersions of piroxicam with hydrophilic carriers. Drug Dev Ind Pharm. 2007 Jan;33(1):45–56.

Swidan S. Design, Formulation and Evaluation of Piroxicam Capsules Prepared by Solid Dispersion Technique. Br J Pharm Res. 2013 Jan 10;3(1):108–34.

Budiarto S, Binarjo A. Enhancement of Piroxicam Intrinsic Dissolution Rate via Solid Dispersion using Beta Cyclodextrin. In: Proceeding of International Conference On Drug Development Of Natural Resources. Faculty of Pharmacy, Ahmad dahlan University, Yogyakarta; 2012. p. 373–80.

Verma MM, Kumar MT, Balasubramaniam J, Pandit JK. Dissolution, bioavailability and ulcerogenic studies on piroxicam-nicotinamide solid dispersion formulations. Boll Chim Farm. 2003 Apr;142(3):119–24.

Mishra DN, Vijaya Kumar SG. Investigations on analgesic, anti-inflammatory and ulcerogenic potential of meloxicam solid dispersion prepared with skimmed milk. Yakugaku Zasshi. 2006 Jul;126(7):495–8.

Vijaya Kumar SG, Mishra DN. Analgesic, antiinflammatory, and ulcerogenic studies of meloxicam solid dispersion prepared with polyethylene glycol 6000. Methods Find Exp Clin Pharmacol. 2006 Sep;28(7):419–22.

Lee EH. A practical guide to pharmaceutical polymorph screening & selection. Asian J Pharm Sci. 2014 Aug;9(4):163–75.

Murthy KS, Ghebre-Sellassie I. Current perspectives on the dissolution stability of solid oral dosage forms. J Pharm Sci. 1993 Feb;82(2):113–26.

Varma V, Sowmya C, Tabasum S. Formulation and Evaluation of Piroxicam Solid Dispersion with Suitable Carrier. Res J Pharm Biol Chem Sci. 2012;3(3):929–41.

Binarjo A. Stabilitas fisika dan kimia rekristal dan dispersi padat piroksikam-PEG 6000. Pharmaciana. 2015 May 31;5(1):61–9.

USP Monographs: Piroxicam Capsules [Internet]. [cited 2016 Aug 31]. Available from: http://www.pharmacopeia.cn/v29240/usp29nf24s0_m65723.html

Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol. 1975 Jan;27(1):48–9.

Wagner J. Biopharmaceutical and Relevant Pharmacokinetic. Carson: Drug Inteligence Publication; 1971.

Dokoumetzidis A, Papadopoulou V, Macheras P. Analysis of dissolution data using modified versions of Noyes-Whitney equation and the Weibull function. Pharm Res. 2006 Feb;23(2):256–61.

Das IJ, Samal HB, Dey S. Enhancement of Dissolution Rate of Piroxicam Using Solid Dispersions With PEG-6000 and Eudragit RL-100. J Pharm Res. 2011;4(5):1473–80.

Shohin IE, Kulinich JI, Ramenskaya GV, Abrahamsson B, Kopp S, Langguth P, et al. Biowaiver monographs for immediate release solid oral dosage forms: piroxicam. J Pharm Sci. 2014 Feb;103(2):367–77.

Shargel L, Yu B. A, Wu-Pong S. Biopharmaceutic Considerations in Drug Product Design and in Vitro Drug Product Performance. In: Applied Biopharmaceutics and Pharmacokinetics. 6th ed. New York: McGraw-Hill; 2012. p. 361–89.

Javadzadeh Y, Hamedeyazdan S, Asnaashari S. Recrystallization of Drugs: Significance on Pharmaceutical Processing. In: Processing. Tehran: Biotechnology Research Center, Faculty of Pharmacy Tabriz University of Medical Sciences; 2013. p. 425–48.

Brittain HG. Theory and Principles of Polymorphic Systems. In: Polymorphisme in Pharmaceutical Solid. 2nd ed. New York: Informa Healthcare; 2009. p. 1–24.

Ansel HC. Pengantar Bentuk Sediaan. 4th ed. Jakarta: UI Press; 2005.

DOI: https://doi.org/10.15416/ijpst.v4i1.7933