In process quality control IPQC of compressed uncoated Orthosiphon aristatus Misai Kucing tablets

Zamree M. S., . and Mohd. Hapizul U. L., . and Hada Masayu D. I., . and Pin K. Y., . and Noor Rasyila M. N., . and Mohd Farhan A. R., . and Mohd Shahrul M. N., . and Firmansyah J. S., . and Nurhazwani M. H., . and Masitah M. T., . (2013) In process quality control IPQC of compressed uncoated Orthosiphon aristatus Misai Kucing tablets. [Proceedings Paper]

Previous anti-oxidant and toxicity study conducted revealed that aqueous extract of Orthosiphon aristatus leaves and stems are rich in phenolic recording more than 70 for its antioxidants score for the first four month of growth without any indication of toxicity towards normal kidney and heart cell. Misai kucing or O. aristatus has been reported to act as filters to remove wastes such as urea or common kidney stones in the kidney and helps to regulate body temperature often associated with muscle pain due to cramps supporting its use in various products formulation such as tea capsules and tablets. Concern pertaining to its quality safety and efficacy however remain an important issue justifying the need to establish a standard quality control of the O. aristatus tablets. From a quality point of view there must be an assurance on the authenticity of O. aristatus related product. For safety in-process quality control IPQC of compressed uncoated O. aristatus tablets must comply with quality standards of National Pharmaceutical Control Bureau NPCB. In this study the control of general appearance involves measurement of attributes such as a tablet;s size surface textures physical flaws and consistency. The shape and dimensions of compressed uncoated tablets are determined by the die fill and puncher during the compression process. The weight thickness diameter and hardness of individual O. aristatus tablets are measured with semi automated tablet tester. The tablet friability is measured using tablet friability tester. For compressed uncoated tablets like O. aristatus tablets the disintegration test is carried out using disintegration tester with water at 37 0 C as testing fluid. The dissolution tester is used to conduct dissolution test. Tablet thickness diameter and hardness for average of ten tablets are consistent at 6.50mm 18.63mm and 240.50 N respectively from batch to batch. The result for friability test tablets is 0.1 and the friability test is considered acceptable because a maximum weight loss is not more than 1 of the weight of the tablets tested. The British Pharmacopoeia requires that the tablets to disintegrate in 15 minutes though it varies for some uncoated tablets. For this compressed uncoated O. aristatus the disintegration process took 27 minutes. The amount of time required for certain percentage of the substance in a tablet to dissolve into solution under a specified set of conditions or dissolution test with maximum of 30 minutes time set as the acceptable by the relevant standard. The compressed uncoated O. aristatus tablets have been produce to contain ample amount of active substance binder disintegrant and glidant to ensure easy disintegration disaggregation and dissolution of the tablet in the stomach or intestine. Equipped with this IPQC knowledge together with other quality assessment it become easier to identify how O. aristatus can be used with minimal adverse effects on the patient as well as compliance to NPCB product registration.

Full text available from:

Abstract

Previous anti-oxidant and toxicity study conducted revealed that aqueous extract of Orthosiphon aristatus leaves and stems are rich in phenolic recording more than 70 for its antioxidants score for the first four month of growth without any indication of toxicity towards normal kidney and heart cell. Misai kucing or O. aristatus has been reported to act as filters to remove wastes such as urea or common kidney stones in the kidney and helps to regulate body temperature often associated with muscle pain due to cramps supporting its use in various products formulation such as tea capsules and tablets. Concern pertaining to its quality safety and efficacy however remain an important issue justifying the need to establish a standard quality control of the O. aristatus tablets. From a quality point of view there must be an assurance on the authenticity of O. aristatus related product. For safety in-process quality control IPQC of compressed uncoated O. aristatus tablets must comply with quality standards of National Pharmaceutical Control Bureau NPCB. In this study the control of general appearance involves measurement of attributes such as a tablet;s size surface textures physical flaws and consistency. The shape and dimensions of compressed uncoated tablets are determined by the die fill and puncher during the compression process. The weight thickness diameter and hardness of individual O. aristatus tablets are measured with semi automated tablet tester. The tablet friability is measured using tablet friability tester. For compressed uncoated tablets like O. aristatus tablets the disintegration test is carried out using disintegration tester with water at 37 0 C as testing fluid. The dissolution tester is used to conduct dissolution test. Tablet thickness diameter and hardness for average of ten tablets are consistent at 6.50mm 18.63mm and 240.50 N respectively from batch to batch. The result for friability test tablets is 0.1 and the friability test is considered acceptable because a maximum weight loss is not more than 1 of the weight of the tablets tested. The British Pharmacopoeia requires that the tablets to disintegrate in 15 minutes though it varies for some uncoated tablets. For this compressed uncoated O. aristatus the disintegration process took 27 minutes. The amount of time required for certain percentage of the substance in a tablet to dissolve into solution under a specified set of conditions or dissolution test with maximum of 30 minutes time set as the acceptable by the relevant standard. The compressed uncoated O. aristatus tablets have been produce to contain ample amount of active substance binder disintegrant and glidant to ensure easy disintegration disaggregation and dissolution of the tablet in the stomach or intestine. Equipped with this IPQC knowledge together with other quality assessment it become easier to identify how O. aristatus can be used with minimal adverse effects on the patient as well as compliance to NPCB product registration.

[error in script]

Item Type:	Proceedings Paper
Additional Information:	Available at Perpustakaan Sultan Abdul Samad Universiti Putra Malaysia 43400 UPM Serdang Selangor Malaysia. QK99 M3S471 2012 Call Number.
AGROVOC Term:	Lamiaceae
AGROVOC Term:	Labiatae
AGROVOC Term:	Herbs herbaceous plants
AGROVOC Term:	Medicinal herbs
AGROVOC Term:	Quality controls
AGROVOC Term:	Performance testing
AGROVOC Term:	Plant extracts
AGROVOC Term:	Dosage
AGROVOC Term:	Weight
AGROVOC Term:	Diameter
Geographical Term:	MALAYSIA
Depositing User:	Ms. Suzila Mohamad Kasim
Last Modified:	24 Apr 2025 05:16
URI:	http://webagris.upm.edu.my/id/eprint/13724

Actions (login required)

View Item