A Guide to Choose the Most Suited Superdisintegrant - General considerations and watchout when optimizing ODT-formulations
(2020) KLGM10 20201Food Technology and Nutrition (M.Sc.)
- Abstract
- The inclusion of a superdisintegrant in an ODT-formulation is necessary to ensure that its disintegration behaviour is on point. However, given the wide array of circumstances that might influence this conduct, it is still very difficult to predict the complete disintegration behaviour of an ODT-formulation. Examples of such circumstances are excipient and API-interaction. In order to reduce these elements, the need to choose the most suited superdisintegrant is of immense importance. Coupled with the choice of superdisintegrant comes however further difficulties, as the disintegration behaviour of different superdisintegrants seems to prosper at different concentrations, tablet compaction force and so on.
Due to these difficulties, a... (More) - The inclusion of a superdisintegrant in an ODT-formulation is necessary to ensure that its disintegration behaviour is on point. However, given the wide array of circumstances that might influence this conduct, it is still very difficult to predict the complete disintegration behaviour of an ODT-formulation. Examples of such circumstances are excipient and API-interaction. In order to reduce these elements, the need to choose the most suited superdisintegrant is of immense importance. Coupled with the choice of superdisintegrant comes however further difficulties, as the disintegration behaviour of different superdisintegrants seems to prosper at different concentrations, tablet compaction force and so on.
Due to these difficulties, a guide concerning the choosing of the most suited superdisintegrant and the accompanying circumstances thereof has been sought to be provided in this thesis, by means of a theoretical and an experimental evaluation. In this theoretical evaluation, most attention was placed in literature studies concerning for example superdisintegrants, the disintegrating action and what parameters that have an impact on this action, which experimental tests to perform, how to perform them and so on. The experimental evaluation consisted of the laboratorial work, which included the manufacturing of the powder mixture and subsequently the tablets, tests regarding the flowability, the disintegration time, wetting time, effect of humidity exposure, the dimensions, the friability and the hardness of the tablets.
The superdisintegrants that have been analyzed in this thesis are Croscarmellose Sodium, Sodium Starch Glycolate, Soy Polysaccharide and Crospovidone. (Less) - Popular Abstract
- In an ever more developing world, the difficulties surrounding the patient compliance of conventional tablets has no place in a futuristic society, making ODT:s one of the solutions for the future of orally consumed pharmaceuticals.
During the last decades, orodispersible tablets or ODT:s has become very popular. This popularity has arisen due to the problems regarding patient compliance that is apparent within certain patient groups when it comes to conventional tablet formulations. The disintegrating action in ODT formulations can be attributed to a particular kind of excipient called superdisintegrants. The disintegrating performance of a particular superdisintegrant in a particular formulation is however a complex business, since it... (More) - In an ever more developing world, the difficulties surrounding the patient compliance of conventional tablets has no place in a futuristic society, making ODT:s one of the solutions for the future of orally consumed pharmaceuticals.
During the last decades, orodispersible tablets or ODT:s has become very popular. This popularity has arisen due to the problems regarding patient compliance that is apparent within certain patient groups when it comes to conventional tablet formulations. The disintegrating action in ODT formulations can be attributed to a particular kind of excipient called superdisintegrants. The disintegrating performance of a particular superdisintegrant in a particular formulation is however a complex business, since it is influenced by a wide array of circumstances, such as interaction with the active substance or the other excipients. Because this complexity is still apparent, it can be difficult to choose the most suited superdisintegrant without carrying out performance tests including different superdisintegrants to determine which is giving the most favourable performance results. To sought out this difficulty, a guide for choosing the most suitable superdisintegrant for any given formulation has been provided in this thesis. The accumulated results in this guide might help reduce the earlier mentioned difficulties in terms of individual superdisintegrant performance in a particular formulation. This might in turn lead to a degree of knowledge concerning superdisintegrant behaviour were by arduous performance tests on formulations containing different superdisintegrants are no longer necessary to determine which superdisintegrant one should include.
The most interesting learnings that was obtained in this thesis work, was the effectiveness in terms of disintegration behaviour concerning the tablets containing Soy Polysaccharide. At high concentrations, tablets containing Soy Polysaccharide displayed the lowest disintegration times as well as the lowest wetting times in comparison to tablets containing the other, more commonly used superdisintegrants.
However, tablets containing low concentrations of Soy Polysaccharide did not show as good disintegration behaviour as tablets containing low concentrations of Croscarmellose Sodium or Crospovidone. Furthermore, 7 kN-tablets containing Soy Polysaccharide or Sodium Starch Glycolate gave a friability value over 1.0%, suggesting that they were too fragile to be approved for manufacturing. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9028301
- author
- Rydhög, Jens LU
- supervisor
- organization
- course
- KLGM10 20201
- year
- 2020
- type
- H2 - Master's Degree (Two Years)
- subject
- keywords
- Superdisintegrants, Pharmaceutical formulations, ODT, Croscarmellose Sodium, Sodium Starch Glycolate, Soy Polysaccharide, Crospovidone, Food technology, Livsmedelsteknologi
- language
- English
- id
- 9028301
- date added to LUP
- 2020-09-25 17:37:26
- date last changed
- 2020-09-25 17:37:26
@misc{9028301,
abstract = {{The inclusion of a superdisintegrant in an ODT-formulation is necessary to ensure that its disintegration behaviour is on point. However, given the wide array of circumstances that might influence this conduct, it is still very difficult to predict the complete disintegration behaviour of an ODT-formulation. Examples of such circumstances are excipient and API-interaction. In order to reduce these elements, the need to choose the most suited superdisintegrant is of immense importance. Coupled with the choice of superdisintegrant comes however further difficulties, as the disintegration behaviour of different superdisintegrants seems to prosper at different concentrations, tablet compaction force and so on.
Due to these difficulties, a guide concerning the choosing of the most suited superdisintegrant and the accompanying circumstances thereof has been sought to be provided in this thesis, by means of a theoretical and an experimental evaluation. In this theoretical evaluation, most attention was placed in literature studies concerning for example superdisintegrants, the disintegrating action and what parameters that have an impact on this action, which experimental tests to perform, how to perform them and so on. The experimental evaluation consisted of the laboratorial work, which included the manufacturing of the powder mixture and subsequently the tablets, tests regarding the flowability, the disintegration time, wetting time, effect of humidity exposure, the dimensions, the friability and the hardness of the tablets.
The superdisintegrants that have been analyzed in this thesis are Croscarmellose Sodium, Sodium Starch Glycolate, Soy Polysaccharide and Crospovidone.}},
author = {{Rydhög, Jens}},
language = {{eng}},
note = {{Student Paper}},
title = {{A Guide to Choose the Most Suited Superdisintegrant - General considerations and watchout when optimizing ODT-formulations}},
year = {{2020}},
}