Formulation and Characterization of Sustained Release Matrix Tablets of Diclofenac Sodium Using Ziziphusmauritiana Lam. Mucilage as a Novel Natural Polymer
Keywords:
Diclofenac sodium, Sustained release, Matrix tablet, Ziziphusmauritiana, Natural mucilage, Swelling index, Drug releaseAbstract
The present study was aimed at formulating and characterizing sustained release matrix tablets of Diclofenac sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), employing mucilage extracted from Ziziphusmauritiana Lam. (Ber) as a novel natural polymer matrix former. Nine formulations (F1–F9) were prepared using dry granulation and wet granulation techniques with varying concentrations of Ziziphus mucilage (12–72 mg) and guar gum as matrix-forming materials. The mucilage was isolated from fresh and dried berries by aqueous extraction and alcohol precipitation and was evaluated for physicochemical properties including swelling index, viscosity, ash values, moisture content, and solubility. Preformulation and post-compression parameters—angle of repose, bulk density, tapped density, Carr's index, Hausner's ratio, hardness, friability, weight variation, thickness, and content uniformity—were assessed for all batches. In vitro drug release studies were conducted in 0.1 N HCl (pH 1.2) for 2 hours followed by phosphate buffer (pH 6.8) for 10 hours using USP Type-I basket apparatus. DSC and HPTLC studies confirmed compatibility between Diclofenac sodium and the excipients. The optimized formulation F9 (12 mg mucilage, wet granulation) exhibited a maximum cumulative drug release of 87.11% over 12 hours, comparable to the marketed formulation Voveran SR 100 (88.01%). A direct inverse relationship between mucilage concentration and drug release rate was established. Results indicate that Ziziphusmauritiana Lam. mucilage is a promising, economical, and eco-friendly natural polymer for sustained release drug delivery systems.
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References
Thanatcha R, Pranee A. Extraction and characterization of mucilage in Ziziphusmauritiana Lam. International Food Research Journal 2011; 18: 201–212.
Deshmukh VN, Sakarkar DM, Singh SP. Development and evaluation of sustained release matrix tablet using hydrophilic gums as release modifier. Journal of Pharmacy Research 2009; 2(2): 1–5.
Gupta PK, Robinson JR. Oral controlled release delivery. In: Kydonieus A (ed). Treatise on Controlled Drug Delivery. Marcel Dekker, New Jersey; 1992. p. 255–310.
Notari RE. Biopharmaceutics and Clinical Pharmacokinetics. Marcel Dekker Inc., New York; 1987.
Greenblatt DJ, van Moltke LL, Harmatz JJ, Shader RI. Pharmacokinetics, pharmacodynamics, and drug disposition. In: Davis KL, Charney D, Coyle JT, Nemerof C (eds). Neuropsychopharmacology. Lippincott, Williams & Wilkins, Philadelphia; 2002. p. 507–524.
Li JW, Fan LP, Ding SD, Ding XL. Nutritional composition of five cultivars of Chinese jujube. Food Chemistry 2007; 103: 454–460.
Li JW, Ding SD, Ding XL. Comparison of antioxidant capacities of extracts from five cultivars of Chinese jujube. Process Biochemistry 2005; 40: 3607–3613.
Nussinovitch A. Hydrocolloid Applications: Gum Technology in the Food and Other Industries. 1st ed. Chapman and Hall, USA; 1997.
Romanchik-Cerpovicz JE, Tilmon RW, Baldree KA. Moisture retention and consumer acceptability of chocolate bar cookies prepared with okra gum as a fat ingredient substitute. Journal of the American Dietetic Association 2002; 102: 1301–1303.
Wu AM, Jiang Y, Huang PY, Shen F. Characterization of the okra mucilage by interaction with Gal, GalNAc, and GlcNAc specific lectins. Biochimica et Biophysica Acta 1995; 1243: 157–160.
Abdel-Aal ESM, Sosulski FW, Sokhansanj S. Bleaching of wheat distillers' grains and its fiber and protein fractions with alkaline hydrogen peroxide. Food Science and Technology / Lebensmittel-Wissenschaft und Technologie 1996; 27(2): 166–172.
AOAC International. Official Methods of Analysis of AOAC International. 18th ed. AOAC International, Gaithersburg, MD, USA. Official Method 2005.08; 2005.
Chau CF, Cheung PCK. Functional properties of flours prepared from three Chinese indigenous legume seeds. Food Chemistry 2005; 61(4): 429–434.
British Pharmacopoeia. Vol. II. Her Majesty's Stationery Office, London; 1988. p. 140.
Kokate CK, Purohit AP, Gokhale SB. Pharmacognosy. 24th ed. NiraliPrakashan, Pune; 2003. p. 109.
Indian Pharmacopoeia. 4th ed. Ministry of Health and Family Welfare, Govt. of India, New Delhi; Controller of Publications; 1996. p. A-54.
British Pharmacopoeia. Vol. 2. Her Majesty's Stationery Office, London; 2000. p. A-207, 210.
Raghavendra SN, Rastogi NK, Raghavarao KSMS, Tharanathan RN. Dietary fiber from coconut residue: effects of different treatments and particle size on the hydration properties. European Food Research and Technology 2004; 218: 563–567.
Obatolu VA, Fasoyiro SB, Ogunsunmi L. Effect of processing on functional properties of yam beans (Sphenostylisstenocarpa). Food Science and Technology 2001; 7(4): 319–322.
Singh SK, Bala R, Arora S, Ahuja S. Isolation and evaluation of binding property of Ziziphusjujuba Lam. seed mucilage in tablet formulations. Journal of Global Pharma Technology 2010; 2(1): 98–102.
Abdu SB, Ehoche OW, Adamu AM, Yashim SM, Jokthan GE. Evaluation of processing methods on biochemical composition of Ziziphus (Ziziphusmauritiana) leaf meal. Tropical Journal of Animal Science 2007; 10(1-2): 441–443.
Tiwari SB, Murthy TK, Raveendra Pai M, Mehta PR, Chowdary PB. Controlled release formulation of tramadol hydrochloride using hydrophilic and hydrophobic matrix system. AAPS PharmSciTech 2003; 4(3): 31.
Rathore SK, Bhatt S, Dhyani S, Jain A. Preliminary phytochemical screening of medicinal plant Ziziphusmauritiana Lam. fruits. International Journal of Current Pharmaceutical Research 2012; 4(3): 160–162.
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