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Effect of processing methods on xylitol-starch base co-processed adjuvant for orally disintegrating tablet application.
Pak J Pharm Sci. 2020 Mar; 33(2):551-559.PJ

Abstract

Orally disintegrating tablet (ODT) is a friendly dosage form that requires no access to water and serves as a solution to non-compliance. There are many co-processed adjuvants available in the market. However, there is no single product possesses all the ideal characteristics such as good compressibility, fast disintegration and good palatability for ODT application. The aim of this research was to produce a xylitol-starch base co-processed adjuvant which is suitable for ODT application. Two processing methods namely wet granulation and freeze drying were used to compare the characteristics of co-processed adjuvant comprising of xylitol, starch and crospovidone XL-10 mixed at various ratios. The co-processed excipients were compressed into ODT and physically characterized for powder flow, particle size, hardness, thickness, weight, friability, in-vitro disintegration time and in-situ disintegration time, lubricant sensitivity, dilution potential, Fourier transform infrared spectroscopy, scanning electronic microscopy and x-ray diffraction analysis. Formulation F6 was selected as the optimum formulation due to the fastest in-vitro (135.33±11.52 s) and in-situ disintegration time (88.67±13.56s) among all the formulations (p<0.05). Increase in starch component decreases disintegration time of ODT. The powder flow fell under the category of fair flow. Generally, it was observed that freeze drying method produced smaller particle size granules compared to wet granulation method. ODT produced from freeze drying method had shorter disintegration time compared to ODT from wet granulation batch. In conclusion, a novel co-processed excipient comprised of xylitol, starch and crospovidone XL-10, produced using freeze drying method with fast disintegration time, good compressibility and palatability was developed and characterized. The co-processed excipient is suitable for ODT application.

Authors+Show Affiliations

Faculty of Pharmaceutical Sciences, UCSI University, No 1, Jalan Menara Gading, UCSI Height, Cheras, Kuala Lumpur, Malaysia/CUCMS University, Persiaran Bestari, Cyberjaya, Selangor, Malaysia.Faculty of Pharmacy, International Islamic University Malaysia, Bandar Indera Mahkota, Kuantan, Pahang, Malaysia.Faculty of Pharmacy, International Islamic University Malaysia, Bandar Indera Mahkota, Kuantan, Pahang, Malaysia.CUCMS University, Persiaran Bestari, Cyberjaya, Selangor, Malaysia.Faculty of Pharmaceutical Sciences, UCSI University, No 1, Jalan Menara Gading, UCSI Height, Cheras, Kuala Lumpur, Malaysia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32276897

Citation

Bin, Liew Kai, et al. "Effect of Processing Methods On Xylitol-starch Base Co-processed Adjuvant for Orally Disintegrating Tablet Application." Pakistan Journal of Pharmaceutical Sciences, vol. 33, no. 2, 2020, pp. 551-559.
Bin LK, Helaluddin ABM, Islam Sarker MZ, et al. Effect of processing methods on xylitol-starch base co-processed adjuvant for orally disintegrating tablet application. Pak J Pharm Sci. 2020;33(2):551-559.
Bin, L. K., Helaluddin, A. B. M., Islam Sarker, M. Z., Mandal, U. K., & Gaurav, A. (2020). Effect of processing methods on xylitol-starch base co-processed adjuvant for orally disintegrating tablet application. Pakistan Journal of Pharmaceutical Sciences, 33(2), 551-559.
Bin LK, et al. Effect of Processing Methods On Xylitol-starch Base Co-processed Adjuvant for Orally Disintegrating Tablet Application. Pak J Pharm Sci. 2020;33(2):551-559. PubMed PMID: 32276897.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of processing methods on xylitol-starch base co-processed adjuvant for orally disintegrating tablet application. AU - Bin,Liew Kai, AU - Helaluddin,Abdul Bashar Mohammed, AU - Islam Sarker,Md Zaidul, AU - Mandal,Uttam Kumar, AU - Gaurav,Anand, PY - 2020/4/12/entrez PY - 2020/4/12/pubmed PY - 2020/4/12/medline SP - 551 EP - 559 JF - Pakistan journal of pharmaceutical sciences JO - Pak J Pharm Sci VL - 33 IS - 2 N2 - Orally disintegrating tablet (ODT) is a friendly dosage form that requires no access to water and serves as a solution to non-compliance. There are many co-processed adjuvants available in the market. However, there is no single product possesses all the ideal characteristics such as good compressibility, fast disintegration and good palatability for ODT application. The aim of this research was to produce a xylitol-starch base co-processed adjuvant which is suitable for ODT application. Two processing methods namely wet granulation and freeze drying were used to compare the characteristics of co-processed adjuvant comprising of xylitol, starch and crospovidone XL-10 mixed at various ratios. The co-processed excipients were compressed into ODT and physically characterized for powder flow, particle size, hardness, thickness, weight, friability, in-vitro disintegration time and in-situ disintegration time, lubricant sensitivity, dilution potential, Fourier transform infrared spectroscopy, scanning electronic microscopy and x-ray diffraction analysis. Formulation F6 was selected as the optimum formulation due to the fastest in-vitro (135.33±11.52 s) and in-situ disintegration time (88.67±13.56s) among all the formulations (p<0.05). Increase in starch component decreases disintegration time of ODT. The powder flow fell under the category of fair flow. Generally, it was observed that freeze drying method produced smaller particle size granules compared to wet granulation method. ODT produced from freeze drying method had shorter disintegration time compared to ODT from wet granulation batch. In conclusion, a novel co-processed excipient comprised of xylitol, starch and crospovidone XL-10, produced using freeze drying method with fast disintegration time, good compressibility and palatability was developed and characterized. The co-processed excipient is suitable for ODT application. SN - 1011-601X UR - https://www.unboundmedicine.com/medline/citation/32276897/Effect_of_processing_methods_on_xylitol-starch_base_co-processed_adjuvant_for_orally_disintegrating_tablet_application DB - PRIME DP - Unbound Medicine ER -
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