Friday, March 22, 2013

Parameters and Specification of Dissolution & Disintegration of Tablets


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 

2 comments:

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