Effects of a direct compressible co-processed novel excipient on the brittle fracture tendency of paracetamol tablets
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Abstract
The objective of the study was to investigate the effects of a novel co-processed excipient on ameliorating the brittle fracture tendency of paracetamol tablets. A novel co-processed excipient was prepared using the suspension-agitation methods. The prepared excipient was mixed in varying proportions with paracetamol powder and used to produce three batches of tablets (M1-M3) by direct compression. Maize starch mucilage (10 %w/v) was used to prepare a batch of paracetamol granules (M4) by wet granulation and compressed into tablets. Pre- and post-compression parameters were evaluated for all batches. Brittle fracture indices (BFI) of the tablet formulations were determined and compared. Pre- and post-compression parameters of the batches met official compendial specifications and were comparable in their micromeritic properties, tablet weight uniformity, friability, crushing strengths, disintegration times and dissolution profiles. The brittle fracture indices of the tablets were not directly proportional to their tensile strengths and disintegration times. Tablets prepared with the co-processed novel excipient gave superior BFIs in the rank order of M4 > M1 > M2 > M3. The M3 batch of novel excipient tablets gave comparable tablet properties with those of maize starch mucilage.
The tensile strengths and brittle fracture tendencies of the novel excipient tablets may suggest that the excipient can be used as an alternative to maize starch mucilage as binder in paracetamol tablet formulations.
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References
Amidon GE, Secreast PJ, Mudie D (2009). Particle, powder and compact characterization. In: Qiu Y, Chen Y, Zhang GGZ, Liu L, Porter W (eds). Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice. Academic Press, Cambridge, MA, pp. 163-186.
Bansal AK, Nachaegari SK (2004). Co-processed excipients for solid dosage forms. Pharm Technol 28: 52-64.
British Pharmacopoeia (2002). Appendix: XII, Disintegration of tablets and capsules. Royal Publishers, London, pp A2-53.
British Pharmacopoeia (2003). Vol. I and II. The Pharmaceutical Press, Her Majesty's Stationery Office, London, pp 249-252.
British Pharmacopoeia (2009). Vol III. The Pharmaceutical Press, Her Majesty’s Stationery Office, London, pp 6578-6585.
Byrn SR., Zografi G, Chen XS (2017). Solid state properties of pharmaceutical materials. First Edition. John Wiley & Sons Inc. New Jersey, pp. 232-248.
Eraga SO, Damisah CO, Uhumwangho MU, Iwuagwu MA (2014). Development and evaluation of novel, multifunctional co-processed excipients for direct compression of paracetamol tablets. J Sci Pract Pharm 1: 25-30.
Eraga SO, Ofulue GE, Iwuagwu MA (2015). The effects of mucilages of three different potato starches on the brittle fracture tendency of paracetamol tablets. Asian J Pharm Health Sci 5: 1293-1299.
Fell JT, Newton JM (1970). Determination of tablet strength by diametral compression test. J Pharm Sci 59: 688-691.
Gohel MC, Jogani PD (2005). A review of co-processed directly compressible excipients. J Pharm Pharm Sci 8: 76-93.
Hiestand EN, Wells JE, Poet CE, Ochs JF (1977). Physical processes of tableting. J Pharm Sci 66: 510-519.
Maarschalk KV, Bolhuis GK (1999). Improving properties of materials for direct compression. Pharm Technol 23: 34-46.
Odeku OA, Itiola OA (2002). Characterisation of khaya gum as a binder in a paracetamol tablet formulation. Drug Dev Ind Pharm 28: 329-337.
Okor RS (2005). Brittle fracture during tableting, problem for the pharmaceutical industry. Trop J Pharm Res 4: 481-482.
Okoye EI, Onyekweli AO, Kunle OO, Arhewoh MI (2010). Brittle fracture index (BFI) as a tool in the classification, grouping and ranking of some binders used in tablet formulation: Lactose tablets. Scientific Res Essays 5(5): 500-506.
Rudnic EM, Schwartz JB (2006). Oral solid dosage forms. In: Troy DB, Beringer P (eds). Remington - The Science and Practice of Pharmacy, Lippincott Williams and Wilkins, Baltimore, pp 889-928.
Uhumwangho MU, Okor RS, Eichie FE, Abbah CM (2006). Influence of some starch binders on the brittle fracture tendency of paracetamol tablets. Afr J Biotechnol 5: 1950-1953.
Wang L, Chen D, Yang L, Zhou F, Dong X (2012). Nonlinear wave propagations in solids and the correlated dynamic behaviour of materials: An overview of the related research works by WLL group in China. Rev. Adv. Mater. Sci. 30:27-59.
Zhou D, Qiu Y (2010). Understanding material properties in pharmaceutical product development and manufacturing: Powder flow and mechanical properties. J Valid Technol 16(1):65-77.