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Comparative Evaluation of Sweet Potato and Peas Starches as Disintegrants in the Foundation of Paracetamol Tablets

Ssemakula Immaculate

Faculty of Pharmaceutics and Pharmaceutical Technology Kampala International University Western Campus Uganda

ABSTRACT

Starch is used as an excipient in pharmaceutical dosage forms such as binder, diluent, disintegrant, absorbent, glidant and sweetener. Starch also has industrial applications as a viscosifier, defoaming and emulsifying agent. However, most of the starch used for these purposes is corn starch and is obtained by importation into Uganda from other countries, which results in a lot of money being utilized in importation of the corn starch which affects the cost of the final products formulated from this starch. The purpose of this research was to determine the disintegrant properties of sweet potato and pea starches in paracetamol tablets. Sweet potatoes and peas are grown locally, hence can be used as alternative sources of starch to corn starch so that the costs of production for pharmaceutical products that require starch can be reduced. In this study, I extracted starch from peas and sweet potatoes in the laboratory and then used it as a disintegrant to formulate paracetamol tablets using the wet granulation method. From the results obtained, starch powders extracted from both peas and sweet potatoes passed the tests that make them suitable for use for pharmaceutical purposes, and the paracetamol tablets formulated using the two starches as disintegrants had the desired disintegration time. However, the results indicated that peas starch had better disintegrant properties than sweet potato starch when used as disintegrants in the formulation of paracetamol tablets. All the paracetamol tablets disintegrated before 15 minutes as recommended by the Bp specification of disintegration time of less or equal to 15 minutes for uncoated tablets. The paracetamol tablets formulated using starch from peas and sweet potatoes disintegrated within 9 minutes and 10 minutes respectively.

Keywords: Disintegrant properties, Sweet potato and pea starches, Pharmaceutical products, Paracetamol tablets, Corn starch.

INTRODUCTION

An excipient is any substance apart from the active pharmaceutical ingredient (API) or prodrug added in pharmaceutical dosage forms. Excipients are added to improve the bulkiness of the dosage form because, without excipients, it’s exceedingly impossible to formulate some APIs into dosage forms. They are also used to enhance bioavailability, improve solubility, increase stability, facilitate dosage form design, increase patient acceptability and assist in the identification of the product. Examples of excipients are diluents, binders, disintegrants, lubricants, glidants, colourants, flavours, sweeteners, coating agents, plasticizers, wetting agents, buffers adsorbents and waxes [1]. There is an increase in starch production in the whole world, with a 25% increase from approximately 60 to 75 million tonnes from 2019 to 2012. The increased demand in countries majorly China and Brazil (+10% per year) has led to this increased production, while other countries have a growth of 1%–2% per year. The major starch output is for use as food but is also used for pharmaceutical purposes as excipients [1]. Starch is a tasteless, soft, white powder that is insoluble in alcohol, cold water and other solvents. Starch is a polysaccharide consisting of glucose monomers connected by 1,4 linkages. It consists of long chains of sugar molecules that are linked together. The most basic form of starch is the linear polymer amylose, while the branched form is amylopectin. The starch molecule has a chemical formula of (C6H10O5) n (Sources for Starch, n.d.) Starch makes up a major source of energy for humans in the whole world and is produced in plants as a reserve carbohydrate [2]. Storage starch granules are produced in amyloplasts with defined structures in various plants, varying from round, oval, ogival or elongated to flat, lenticular or polyhedral, and sizes from sub-microns to more than 100 µm in diameter [2]. Different plants can be a source of starch. Plants such as sweet potato, cassava, corn (cereals), wheat and potato constitute the major source, whereas sorghum, barley, rice and peas are the insignificant sources of starch [1]. The intrinsic physical and chemical characteristics of starch are affected by the starch source, how old the plant source is and also the conditions of the environment during the development of starch. This is because these factors affect the crucial components of starch mainly the amount of the amylose and amylopectin and their quantities. This in turn influences the properties of the products formulated from these starches, more so the pharmaceutical dosage forms (Access, n.d.) Starch is used in pharmaceutical formulations as a binder, disintegrant, diluent, absorbent, glidant/lubricant and sweetener in different dosage forms.(Access, n.d.) while industrial applications include; used as viscosifiers, defoaming and emulsifying agents, and also as encapsulation and sizing agents. Starch for industrial purposes is used in modified form [3]. Pharmaceutically used starch can be obtained by the addition of functional groups using derivatization techniques such as esterification, cationization, cross-linking or hydrolysis and oxidation or physical by use of heat and moisture, gelatinization, extrusion, granulation, agglomeration or spray drying. These modifications are made on the home-grown starch to overcome its inability to withstand some processing conditions such as high temperatures, varying pH, freeze-thaw cycles, its tendency for retrogradation and decomposition, and brittleness(Access, n.d.) Sweet potatoes, Ipomoea batatas(L) Lam, are root tubers which are full of nutrients and they are used as food all over the world. Sweet potatoes belong to the family Convolvulaceae and they can live for more than two years, this plant is native to the central and southern parts of America [4]. But it is now produced in African countries including Nigeria, Tanzania, Ethiopia and Uganda. In Africa, Uganda now leads in the production of sweet potatoes. According to Uganda Bureau of Statistics, total production of sweet potatoes in Uganda was 1.8 million by 2016. The crop is being grown in all the regions of the country, with the highest production being done by the Eastern region by Iganga, followed by the central region Nakasongola, the northern region by Gulu and then the western region by [5].

CONCLUSION

From this study, it can be concluded that Ipomoea batatas starch and Pisum sativum starch can be used as disintegrants in the formulation of paracetamol tablets. However, Pisum sativum starch as a disintegrant can be used to formulate paracetamol tablets with better disintegrant properties than the paracetamol tablets formulated by Ipomoea batatas.

Recommendations

Further studies should be carried out by local Pharmaceutical industries to evaluate all the properties of Ipomoea batatas and Pisum sativum starch powders relating to their compatibility with other commonly used ingredients, so that after various studies, regulatory bodies finally approve the use of Ipomoea batatas and Pisum sativum starch powders as disintegrants in formulation of paracetamol tablets.

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CITE AS: Ssemakula Immaculate (2023). Comparative Evaluation of Sweet Potato and Peas Starches as Disintegrants in the Foundation of Paracetamol Tablets. IDOSR JOURNAL OF SCIENTIFIC RESEARCH 8(3) 84-98. https://doi.org/10.59298/IDOSR JSR /2023/00.7.6000

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