Comparative Assessment of Ginger and Cassava Starch as a Binder on Ibuprofen Tablet Formulation

Abstract

Using the wet granulation method of tablet formulation, ibuprofen tablets were formulated with binder concentration of 2%, 4% and 6% w/w respectively. The compressional, mechanical and dissolution properties were analyzed using density, crushing strength and dissolution methods. The result obtained showed that tablets made with ginger starch had acceptable crushing strength and dissolution rate. The disintegration time for 2%, 4% and 6% w/w ginger starch were 22.25, 17.07 and 33.17 minutes respectively and that for cassava starch 34.24, 29.16 and 33.35 minutes respectively. The 2% w/w of the ginger and cassava starches did not fall within the standard limit of the hardness test (4–8 kg) but rather values of 8.55 kg and 8.45 kg respectively were obtained and this may be linked to the thresh hold of the concentration of the binder not being attained. All the formulations passed the qualitative analysis but that consisting of 4% w/w ginger starch performed excellently in the entire tests hence ginger starch of such concentration could be a very suitable excipient for ibuprofen tablet formulation as compared to cassava starch of the same percentage composition. Key-words: Ginger, Cassava, Ibuprofen, Starch, Tablet, Natural biodegradable biopolymer INTRODUCTION Binders as agents impart cohesive qualities to powdered material during the production of tablet. They impact such properties to the tablet formulation by ensuring that the tablet remains intact after compression as well as improving free powder flowing quality . Binders have been used as solutions and in dry form depending on nature of another ingredient in the formulation and method of preparation. The choice of a particular binding agent depends on the binding force required, compatibility with other ingredients, particularly the active pharmaceutical ingredient (API) . Important materials commonly used as binders are starch, gelatin, natural gum, sugar, acacia, polyethylene glycol, water etc . Starch is the most common binder and pharmaceutical excipient used in tablet formulation How to cite this article Ordu JI, Onyemelukwe JI. Comparative Assessment of Ginger and Cassava Starch as a Binder on Ibuprofen Tablet Formulation. Int. J. Life Sci. Scienti. Res., 2018; 4(3): 1834-1843. Access this article online www.ijlssr.com to impart cohesion on powder mix during tablet formulation. Starch as one of the most abundant organic chemicals on earth is found in the leaves of green plants and on the plastids where it is synthesized from seeds, roots, and tubers of most plants serving as the chemical storage form of energy . Starch is a natural biodegradable biopolymer which has wide industrial application, a quantitatively important digestible polysaccharide regarded as nutritionally superior to low molecular weight carbohydrate or sugar .Maize and potato starch has been in common use and recently cassava starch . Another type of starch currently under study is ginger starch as a binder in the pharmaceutical industry. The type and binder concentration could impart a direct effect on tablet properties such as crushing strength, friability, disintegration and tablet dissolution. Ginger (Zingiber officinale) is an herbaceous perennial plant belonging to the order scitaminaceae and family Zingiberaceae. Harvest of natural ginger is determined by the age of the leaves and bulb size and it contains such compounds as starch, fat, gingerol and volatile oil. The starch is mainly used as an indicator, the excipient in Research Article Int. J. Life Sci. Scienti. Res. eISSN: 2455-1716 Ordu and Onyemelukwe, 2018 DOI:10.21276/ijlssr.2018.4.3.15 Copyright © 2015 2018| IJLSSR by Society for Scientific Research under a CC BY-NC 4.0 International License Volume 04 | Issue 03 | Page 1835 tablet formulation and also for other purposes where it serves as a thickening agent and binding agent . Cassava (Manihot esculenta) is a perennial shrub with an edible root which grows in tropical and sub-tropical areas of the world. Cassava is propagated by stem cutting [8] and the major constituent is starch especially from the cassava tuber and this starch is often recommended for use in extruded snacks for improved expansion. The cassava starch is also used as a thickener in food not subjected to rigorous processing condition. It is very bland in flavor hence used in processed baby foods and as a filer material and binding agents in the confectionary industry . Ibuprofen is a non-steroidal anti-inflammatory drug (NSAIDs), a first member of the propionic acid derivative which occurs as a white powder or crystals with a characteristic odor. Fig. 1: Chemical structure of Ibuprofen Ibuprofen is soluble in aqueous solution of alkali hydroxide and carbonate but slightly soluble in water and has a melting point of about 76°C . Ibuprofen has a prominent analgesic and anti-pyretic effect, which is due to the inhibitory action on cyclooxygenases involved in the synthesis of prostaglandin that plays important role in the production of pain, fever, and inflammation . Ibuprofen is well absorbed orally, peak serum concentration is reached within 1–2 hours after drug administration and the drug is eliminated within 24 hours after the last dose through metabolism. The dose of ibuprofen for an adult is 1.2 g daily in divided doses, while that for children is 20 mg/kg body weight daily, but not above 500mg for children with weight less than 30kg, as overdose may lead to toxicity. such as acute renal failure, aplastic anaemia, neutropenia and thrombocytopenia. Ibuprofen decreases the effect of aspirin by blocking the active site of platelet cyclo-oxygenase, hence it should be administered 8 hours before aspirin, or at least 2–4 hours after aspirin. Ibuprofen is available in the following dosage forms as tablet, capsules, chewable tablets, and oral suspension and usually manufactured as 200 mg or 400 mg ibuprofen in a tablet and 100 mg/50 mg in oral suspension and it should be taken after a meal because it can lead to damage of stomach or intestinal lining, if taken before a meal. Tablets are solid preparation each containing a single dose of one or more active ingredients and usually obtained by compressing uniform volumes of particles. It is the most popular dosage form in existence among all dosage forms because of the convenience of selfadministration, chemical and physical stability, cheapness, versatile way of use and delivery, compactness and ease of manufacturing . Certain numbers of chemically inert materials known as adjunct or excipients are added to the active pharmaceutical ingredient and their classification is based on their processing functions and finished products such as binders, lubricants, glidants, disintegrants, etc. Such excipients should be bound with certain quality criteria as nontoxic, physiologically inert, relatively cheap and acceptable to regulating agencies in all countries . The aim of this study is to evaluate and compare the binding activity of extracted ginger and cassava starch on ibuprofen tablet formulation. MATERIALS AND METHODS Experimental MaterialsIbuprofen powder (BDH, England), magnesium stearate, lactose, maize starch, talc, pH meter (Jenway 3510, England), Electronic balance (Adventurer AR 2130, England) dissolution Apparatus (Erweka TBH 600, Germany), disintegration apparatus (Erweka ZT, 122, Germany), UV spectrometer (Jenway 6405, England), fribilator (Erweka TAR 220, Germany), hardness tester (ErwekaTBH 100, Germany), Ginger and cassava starch (processed in pharmaceutical technology laboratory, University of Port Harcourt, Nigeria. Solubility determination of ibuprofen powderA 0.1 g quantity of ibuprofen powder was weighed (Table 1) and each transferred into six test tubes, various solvents (acetone, sodium hydroxide, water, n-hexane, HCL and chloroform) (10 ml each) were respectively introduced into each of the six test tubes, containing the drugs, shaken and observed for solubility. Int. J. Life Sci. Scienti. Res. eISSN: 2455-1716 Ordu and Onyemelukwe, 2018 DOI:10.21276/ijlssr.2018.4.3.15 Copyright © 2015 2018| IJLSSR by Society for Scientific Research under a CC BY-NC 4.0 International License Volume 04 | Issue 03 | Page 1836 Table 1: Preparation of Ibuprofen granules Ingredients Weight per tablet (mg) Weight in 150 tablets (g)