1.16H DOSAGE FORMS OF HERBAL DRUGS -

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Thai Herbal Pharmacopoeia

สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข

Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health

1.16H DOSAGE FORMS OF HERBAL DRUGS

TABLETS

This appendix should be read in conjunction with Appendix 1.16 under Tablets.

Tablets are solid dosage forms containing one or more active ingredients. They are obtained by single or multiple compression (in certain cases they are moulded) and may be uncoated or coated, i.e., sugar-coated and film-coated. They are usually intended for oral administration.
The different categories of tablets that exist include extract tablets, semi-extract tablets, and powdered crude drug tablets. Tablets are normally circular in shape and their surfaces are flat or convex.
Tablets may have lines or break-marks, symbols, or other markings. They should be sufficiently hard to withstand handling, including packaging, storage, and transportation, without crumbling or breaking. Tablets may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, colouring matter, and flavouring substances. When such excipients are used, it is necessary to ensure that they do not adversely affect the stability, safety, or efficacy of the active ingredient(s); there must be no incompatibility between and of the components of the dosage form.

Disintegration Tablets comply with the “Disintegration Test for Tablets and Capsules” (Appendix 4.23), provided that the time limit is 30 minutes for uncoated tablets, 60 minutes for film-coated tablets, and 90 minutes for other coated tablets.

Weight variation Weigh accurately twenty tablets and calculate the average weight. Weigh individually each of the twenty tablets and compare the weight of each tablet with the average weight (if assay is not required, the weight of each tablet should be compared with the labelled weight). Unless otherwise directed in the monograph, not more than two of the individual weights deviate from the labelled weight or the average weight by more than the weight variation limit shown in the table and none deviates by more than twice that percentage.

Average Weight or Labelled Weight	Weight Variation Limit
< 300 mg	± 7.5 per cent
≥ 300 mg	± 5.0 per cent

Before being coated with sugar, the tablet cores shall comply with the test for weight variation. Sugar-coated tablets are not required to comply with the test for weight variation while film-coated tablets are.

THP 2021 Supplement 2023 • 1.16H DOSAGE FORMS OF HERBAL DRUGS

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Thai Herbal Pharmacopoeia

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1.16H DOSAGE FORMS OF HERBAL DRUGS