Solid oral dosage form manufacturing using injection moulding

Wood, Sarahjane and Halbert, Gavin and Florence, Alastair (2017) Solid oral dosage form manufacturing using injection moulding. In: CMAC Annual Open Day 2017, 2017-03-23 - 2017-03-24, Technology and Innovation Centre, University of Strathclyde.

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Abstract

The most preferred route of drug administration is via an oral dosage form and currently the most widely used manufacturing method is direct compression of powder blends. However it can be difficult to control the homogeneity of these dosage forms due to inefficient mixing. Dispersing API within a molten polymer can give more control over the spatial arrangement of drug within the dosage forms resulting in higher quality doses. Using polymers also has the added benefit that drug-polymer interactions can increase solubility of drugs reducing the growing concern of the number of aqueous insoluble drugs on the market (1). Injection Moulding (IM) is a novel method to produce dosage forms. It works by melting formulations containing polymer and drug together and injecting it into a cavity. By combining this technology with Hot Melt Extrusion (HME) which introduces highly efficient mixing the drug dose can be controlled. However the main disadvantage to using polymers is that sustained release often occurs due to the slow erosion properties and high pressures used during injection moulding(2). Stability issues can also occur when using high drug loadings as the polymer becomes saturated. Disintegrating agents can be introduced to the formulation in order to increase the time taken to obtain complete drug release. It is important to note that due to the nature or polymer true ‘disintegration’ won’t occur as it does with compressed tablets however they do have the ability to help facilitate the breakdown of polymers(3) . Filaments were produced using HME based on a Design of Experiments approach were analysed using disintegration apparatus and the results suggests the best disintegrating agents to use were small natural molecules. However the main factor influencing the mass remaining was the concentration of API as this was a BCS Class II drug. References 1. Karataş A, Yüksel N, Baykara T. 'Improved solubility and dissolution rate of piroxicam using gelucire 44/14 and labrasol'. Il Farmaco. 2005;60(9):777-82. 2. Claeys B, Vervaeck A, Hillewaere XKD, Possemiers S, Hansen L, De Beer T, et al. 'Thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding'. E. J. Pharm. Biopharm. 2015;90:44-52. 3. Agrawal A, Dudhedia M, Deng W, Shepard K, Zhong L, Povilaitis E, et al. 'Development of tablet formulation of amorphous solid dispersions prepared by hot melt extrusion using quality by design approach'. AAPS PharmSciTech. 2016;17(1):214-32.

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