Formulation and evaluation of fast disintegrating tablets for a pharmaceutical product

Abstract

A new pharmaceutical product suitable to act as a negative contrast agent for Computerized Scan (CT-scan) of the abdomen is under development. At the moment the product has the form of a powder, which when dispersed in water and whipped, gives a stable foam. The foam is ingested by individuals who are about to undergo a CT-scan, as a prior preparation step. The powder form has disadvantages such as dosage accuracy and the idea is to develop a tablet that will solve this issue and permit the automatization of foam preparation. At this stage, the aim was to investigate the possibility of making functional tablets of adequate hardness, low friability that will disintegrate rapidly when immersed in water. After whipping the foam should have acceptable properties, in terms of foamability and stability.
The tablets were produced by direct powder compression. Different excipients were added to the initial powder blend to improve disintegration time, hardness, friability and facilitate tableting operations. Two different composites that act as binders were used in an attempt to improve disintegration time and powder compactability. Three different combinations of two disintegrants were tested to investigate which one gives the best disintegration results. A lubricant was also used to reduce adhesion of the powder to the tablet press. Lastly four different compression levels were applied on the powder blends to specify the optimum that gives fast disintegrating tablets of adequate hardness and friability.
The results show that the initial powder blend (mentioned as APL blend) has good flowing properties but poor compactability which gives as a consequence tablets of low hardness and unacceptable friability, that do not disintegrate. The powder blends with the added excipients that were tested show fairly good flowing properties, greatly improved compactability, that resulted in enhanced hardness and friability and vary in time that they need to disintegrate. Optimal levels of compression are indicated for a fast disintegrating, good quality tablet. Foamability remains in acceptable levels even though reduced by the addition of excipients. Foam stability measured three hours after whipping was not significantly influenced.

Popular Abstract

A new pharmaceutical product that acts as a contrast agent for examining the small intestine is being developed by an R&D company. Currently the product exists as a powder form which is poured into water and whipped in order to produce a stable drinkable foam as a preparation step before the scanning of the abdomen.
There is a keen interest in developing a tablet from this powder. The reason behind this is that a tablet is more accurate in terms of the dosage and can be used by a dispensing machine, that will automatically produce the final foam, without the need for engaging a nurse.
Some preliminary trials of tablets made with the existing powder showed that the ingredients when compressed in a tablet form do not facilitate the breaking down of the tablet when immersed in water. These ingredients hinder the penetration of water into the core of the tablet, making the whole project not feasible. The same happened after the addition of pharmaceutical ingredients that help the tablets to break down. Thus, there was a need to alter the formulation by adding composites that promote a fast break down.
This project was about comparing different pharmaceutical ingredients (excipients) and compressions to distinguish which combination gives tablets of the best quality, which will be hard enough not to brake during handling but at the same time they will break down as fast as possible when in water. Finally, an important parameter for the functionality of this product was that the foam should be unaffected as much as possible by the addition of these ingredients. The ability to produce a good quality of foam that will be stable long enough was also measured to ensure that the product would not lose its principle purpose.

• author: Pitsiladis, Anastasios
• supervisor: Björn Bergenståhl
• organization: Food Technology and Nutrition (M.Sc.)
• course: KLGM01 20191
• year: 2019
• type: H2 - Master's Degree (Two Years)
• subject: Agriculture and Food Sciences; Technology and Engineering
• keywords: Tablets, albumen, xanthan gum, powder flow, compactability, tablet strength, disintegration time, tablet weight, foamability, foam stability, food technology, livsmedelsteknologi
• language: English
• id: 8984538
• date added to LUP: 2019-09-12 15:42:49
• date last changed: 2019-09-12 15:42:49