Tablets (Disintegration & Dissolution) Tablets are solid preparations each containing a single dose of one or more active substances. They are obtained by compressing uniform volumes of particles or by another suitable manufacturing technique, such as extrusion, moulding or freeze- drying (lyophilisation). Tablets are intended for oral administration. Some are swallowed whole, some after being chewed, some are dissolved or dispersed in water before being administered and some are retained in the mouth where the active substance is liberated. The particles consist of one or more active substances with or without excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the preparation in the digestive tract, colouring matter authorised by the competent authority and flavouring substances. Several categories of tablets for oral use may be distinguished: · uncoated tablets; · coated tablets; · effervescent tablets; · soluble tablets; · dispersible tablets; · orodispersible tablets; · gastro-resistant tablets; · modified-release tablets; · tablets for use in the mouth; · oral lyophilisates. |
Disintegration:
Type of Tablet | Media | Specification | For Out of Specification |
UNCOATED TABLETS | Water (37°C ± 2°C) | Not More Than 15 minutes with disc | Repeat the test on a further 6 Tablets |
Film-coated Tablets | Water (37°C ± 2°C) | Not More Than 30 minutes with disc | Repeat the test on a further 6 Tablets |
Enteric Coated Tablets | 0.1 M hydrochloric acid without disc (37°C ± 2°C) (after 2 hours replace 0.1 M HCl Solution with the phosphate buffer) | 2 hours remains intake | Repeat the test on a further 6 Tablets |
phosphate buffer solution pH 6.8 (with disc) (37°C ± 2°C) | Not More Than 60 minutes with disc | ||
Effervescent Tablet | 200 ml Water (15-25 °C) | Not More Than 5 minutes | Repeat the test on a further 5 Tablets |
Soluble Tablet | Water (15-25 °C) | Not More Than 3 minutes | Repeat the test on a further 6 Tablets |
Dispersible Tablets | Water (15-25 °C) | Not More Than 3 minutes | ------- |
Orodispersible Tablets | ------ | Not More Than 3 minutes | ------ |
Dissolution: Four types of apparatuses are now described in the British and European Pharmacopoeias; the basket, the paddle, the reciprocating cylinder and the flow-through cell. The descriptions are concordant with those published in the United States Pharmacopeia (USP). Of the two established apparatuses (basket and paddle) the paddle is now the apparatus of choice for many preparations. However, where a published test uses the basket, work to validate a change to the paddle method is not contemplated. The reciprocating cylinder is useful for pH profiling studies while the flow-through cell may be appropriate for preparations of poorly soluble active ingredients (see Annex). Test conditions The harmonised test conditions included in Appendix XII B1 will be applied to all new monographs of the British Pharmacopoeia. It is not the intention of the British Pharmacopoeia Commission to apply these criteria retrospectively to existing monographs. Where an individual monograph prescribes the use of the requirements stated under Monographs of the British Pharmacopoeia in Appendix XII B1, the following conditions using the basket or paddle apparatus are preferred. Ø rotation speed:100 rpm (basket), 50 rpm (paddle) Ø dissolution medium volume: 900 ml Ø dissolution medium composition: aqueous, commonly 0.1M hydrochloric acid or phosphate buffers of pH 6.8 to 7.6 Ø number of units tested: 6 (plus 6, if a retest is required). The number of units tested is specified in Appendix XII B1; other conditions are specified in the relevant individual monographs. In situations where it has been demonstrated that the harmonised criteria are not applicable (e.g. low solubility preparations, 'coning' of material in the vessel, low concentration of analyte), modifications may be made to the test conditions, such as, adding a surfactant, increasing the paddle rotation speed or using a modified vessel and reducing the volume of dissolution medium used. |
Dissolution:
Type of Tablet | Media | Specification | For Out of Specification |
UNCOATED TABLETS | 0.1 M hydrochloric acid / phosphate buffer solution / Water (37°C ± 0.5°C) | Should not be released less than 70% of labeled amount at 45 minutes | Repeat the test on a further 6 Tablets |
Film-coated Tablets | 0.1 M hydrochloric acid / phosphate buffer solution / Water(37°C ± 0.5°C) | Should not be released less than 70% of labeled amount at 45 minutes | Repeat the test on a further 6 Tablets |
Enteric Coated Tablets | (media for 2 hours) 0.1 M hydrochloric acid (37°C ± 0.5°C) | Should not be released more than 10% of labeled amount after 2 hours | Repeat the test on a further 6 Tablets |
Then replace the 0.1 M HCl by phosphate buffer solution pH 6.8 (37°C ± 0.5°C) | Should not be released less than 70% of labeled amount at 45 minutes |
Source: BP 2013