The Development of Para-Aminosalicylic Acid Sodium Multiple Units Controlled Release Dosage Forms

Main Article Content

Jomjai Peerapattana
Warinda Rakpanich
Jintana Napaporn

Abstract

The objective of this study was to develop para-aminosalicylic acid sodium (PAS) multiple units controlled release dosage forms. PAS granules were prepared by wet granulation method. The characteristics of these granules were studied i.e. size and size distribution, friability and content uniformity. PAS granules were subcoated with HPMC E50 1, 3 and 5% loading (w/w) and then enteric coated with Eudragit® L 30D55 10, 20 and 30% loading (w/w) by using fluidized bed bottom spray coater. In vitro drug release studies of coated PAS granules were performed in 0.1 N HCl for 2 hours and replaced with phosphate buffer pH 6.8 for 1 hour. It was found that, formula 18-9 (3% HPMC + 30% Eudragit®) and 18-11 (5% HPMC + 20% Eudragit®) met the acceptance criteria of dissolution of delayed release dosage forms. Those are no individual unit dissolved more than 10% within 2 hrs in 0.1 N HCl and not less than 80% of labeled amount of drug is dissolved in phosphate buffer pH 6.8 within 45 minutes.

Downloads

Download data is not yet available.

Article Details

Section
Pharmaceutical Sciences

References

Akhtar AJ, Crompton GK, Schonell ME. Malabsorption induce by PAS. Br Med J 1969; 17(2): 449.
Aleksandra D, Raoul M, Peter A, Pual F, Jan G. Development of starch-based pellets via extrusion/spheronisation. Eur J Pharm Biopharm 2007; 66(1): 83-94.
Allagh TS, Ibrahim YKE, Ojile JE. Drug distribution in granules: Effect of diluents and granule size on the distribution of a hydrophilic low dose drug in granules. Nig J Pharm Sci 2009; 8(1): 32-40.
Ancuta CF, Dumitru L, Teodora DB, Oana K, Emma B. The infl uence of some diluents on the release of metoprolol tartrate from prolonged release matrix tablets. Prac Pharm 2011; 4(3): 192-4.
Bodmeier R. Tableting of coated pellets. Eur J pharm Biopharm 1997; 43(1): 1-8.
Moffat AC, Osselton MD, Widdop B, Clarke EGC, editors. Clarke’s Analysis of Drugs and Poisons. 3rd ed. London: Pharmaceutical Press; 2004.
Digranes A, Josefsson K, Schreiner A. Infl uence of food on the absorption of erythromycin from enteric coated pellets and stearate tablets. Curr Ther Res 1984; 35(3): 313-20.
Edgar B, Bogentoft C, Lagerstrom PO. Comparison of two enteric-coated acetylsalicylic acid preparations by monitoring steady-state levels of salicylic acid and its metabolites in plasma and urine. Biopharm Drug
Dispos 1984; 5(3): 251-60.
Graffner C, Josefsson K, Stockman O. Intra- and intersubject variation of erythromycin absorption from single unit and multiple units enteric coated products. Biopharm Drug Dispos 1986; 7(3): 163-71.
Joseffson K, Levitt MJ, Kann J, Bon C. Erythromycin absorption from enteric-coated pellets given in multiple doses to volunteers in comparison with enteric-coated tablets and fi lm-coated stearate tablets. Curr Ther Res 1986; 39(1): 131-42.
Lacy CF, Armstrong LL, Goldman MP, Lance LL, editors. The drug information handbook. 20th ed. Hudson: Lexi-Comp; 2011.
Lakshmi PJ, Deepthi B, Rama R. Infl uence of diluents on diclofenac sodium release from gum kondagogu based matrix tablets. IJPRR 2012; 1(4); 12-20.
Melia CD, Washington N, Wilson CG, editors. Multiparticulate controlled release oral dosage forms: technology and biopharmaceutics. Edinburgh: Scottish Academic Press; 1994.
Moffat AC, Osselton MD, Widdop B, Clarke EGC, editors. Clarke’s Analysis of Drugs and Poisons. 3rd ed. London: Pharmaceutical Press; 2004.
Pandey VP, Reddy KV, Amarnath R. Studies on diluents for formulation of tablets. Int J Chem Sci 2009; 7(4): 2273-7.
Peloquin CA, Henshaw TL, Huitt GA, Berning SE, Nitta AT, James GT. Pharmacokinetic evaluation of para-aminosalicylic acid granules. Pharmacotherapy 1994; 14(1): 40-6.
Raymond CR, Paul JS, Marian EQ, editors. Handbook of pharmaceutical excipients. 6th ed. Chicago: Pharmaceutical Press; 2009.
Sanghavi NM, Venkatesh H, Mahalaxmi D, Shiravadekar HS. In vivo evaluation of pindolol multi-unit dosage forms. Drug Dev Ind Pharm 1995; 21(16): 1917-21.
Shi L, Feng Y, Sun CC. Origin of profound changes in powder properties during wetting and nucleation stages of high-shear wet granulation of microcrystalline cellulose. Powder Technol 2011; 208: 663–668
Umubyeyi A, Rigouts L, Shamputa IC, Dediste A, Struelens M, Portaels F. Low levels of second-line drug resistance among multidrug-resistant Mycobacterium tuberculosis isolates from Rwanda. Int J Infect
Dis 2008; 12(2): 152-6.
United States Pharmacopeial Convention. The United States Pharmacopeia 30 The National Formular 25. Philadelphia: United States Pharmacopeial Convention; 2007.
World Health Organization. Treatment of tuberculosis guidelines. 4th ed. Geneva: WHO; 2011.