DESIGN AND EVALUATION OF MICROCRYSTALLINE TAPIOCA STARCH AND ITS UTILISATION IN THE FORMULATION OF MICROCRYSTARLAC AND MICROCRYSTARCELLAC FOR DIRECT COMPRESSION

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Date
2012-09
Authors
OYETUNJI, SHITTU,
ABIODUN
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Abstract
ABSTRACT Native tapioca starch (NTS) was modified by annealing and enzyme hydrolysis to obtain microcrystalline tapioca starch (MCTS), which was coprocessed with α-lactose monohydrate (LMH) to form Microcrystarlac (MSL). MCTS was also coprocessed with LMH and microcrystalline cellulose (MCC) to yield Microcrystarcellac (MSCL). NTS was extracted from cassava tuber (Mannihot esculenta Crantz) using a standard method. The powder suspensions were prepared at a concentration of 40 %w/v in five separate conical flasks. The starch granules were annealed for 1 h to obtain annealed tapioca starch (ATS) which was subsequently hydrolyzed with α-amylase at 60o and pH 7 for 1, 2, 3, 4, and 5 h in a water bath. The reaction was terminated and neutralized with 0.1 N HCl and 0.1 N NaOH respectively. The MCTS was washed, recovered by sedimentation and air dried at room temperature for 72 h. Following characterization, sieve fraction >75-250 μm from granules modified for 3 h was coprocessed with LMH at concentrations of 10 to 50 % w/w as a dried mass relative to MCTS. In another development MCTS was coprocessed with LMH and MCC at concentrations of 10-50 % (MCTS), 45-25 % ( α-LMH) , 45-25 % (MCC). Granule size ranges >75 - 250 μm, and >90 - 250 μm were characterized and compacted at a range of compression load 2.5 to 12.5 KN. The average granule sizes of NTS, ATS, and MCTS were 10 + 0.3 μm, 11.5 + 0.3 μm, and 13+ 0.5 μm respectively. Average flow rate, angle of repose and Carr’s index were 2 g/s, 43o, 50% respectively for NTS, 2.5 g/s, 35o, 37.5 % for MCTS, and 3 g/s, 32o, 22 % for MSL (granule size range >90 - 250 μm and component ratio, 50:50). - 7 - The corresponding values for the direct physical mixture of MCTS and lactose were 0.65 g/s, 40o, 53 %. In terms of flowability and compressibility, MSL exhibited improved functionality over direct physical mixture of the primary excipients. Average flow rate, angle of repose and Carr’s index were 2 g/s, 31.6o, 13.4 % for MSCL (granule size range >90 - 250 μm and component ratio of MCTS, α-LMH, and MCC was 20: 40:40). The corresponding values for the direct physical mixture of MCTS, α-LMH and MCC were 0.45 g/s, 47.5o, 52 %. Based on the flow rate and Carr’s index, MSCL had improved functionality over direct physical mixtures of the primary excipients. The crushing strength for NTS, ATS and MCTS were: 30 N, 90 N and 100 N after 3 h of annealing and hydrolysis respectively, at compression pressure of 6 metric ton. The onset of plastic deformation Py (yield value) were: MSCL (22.3 MNm-2) > Cellactose (24.2 MNm-2) > MSL (68 MNm-2) > MCTS (143 MNm-2) = Starlac (143 MNm-2). The degree of plastic deformation occurring during compression (Pk) was in the following order: MSCL (16.3 MNm-2) > MSL (16.4 MNm-2) > Cellactose® (17 MNm-2) > MCTS (17.7 MNm-2) > Starlac® (19.1 MNm-2). The dilution potential obtained for MCTS, MSL, and MSCL compacted with paracetamol (PCM) and ascorbic acid (AA) as active drug (API) were: 40 % AA with MCTS; 45 % PCM with MSL, 30 % AA with MSL; 50 % AA with MSCL, 45 % PCM with MSCL. The crushing strength of MCTS-40 % AA tablets was found to be 58 N; MSL- 45 % PCM, 80 N; MSCL- 45 % PCM, 70 N; MSCL -50 % AA, 68 N. The T90% of tablet formulations of MCTS, MSL, and MSCL containing PCM and AA ranged from 12-14 min. They compared favourably with Cellactose® and much better than Starlac ®. - 8 - MSL and MSCL were rated equal with Cellactose® in PCM tablet formulation and better in functionality than Starlac ®.
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A DISSERTATION SUBMITTED TO POST GRADUATE SCHOOL AHMADU BELLO UNIVERSITY, ZARIA NIGERIA
Keywords
DESIGN, EVALUATION, MICROCRYSTALLINE, TAPIOCA, STARCH, UTILISATION, FORMULATION, MICROCRYSTARLAC, MICROCRYSTARCELLAC, DIRECT, COMPRESSION
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