High Content Solid Dispersions for Dose Window Extension: A Basis for Design Flexibility in Fused Deposition Modelling
Artikel i vetenskaplig tidskrift, 2020

Purpose: This study uses high drug content solid dispersions for dose window extension beyond current demonstrations using fused deposition modelling (FDM) to; i) accommodate pharmaceutically relevant doses of drugs of varying potencies at acceptable dosage form sizes and ii) enable enhanced dose flexibility via modular dosage form design concepts. Methods: FDM was used to generate ~0.5 mm thick discs of varying diameter (2–10 mm) from melt-extruded feedstocks based on 10% to 50% w/w felodipine in ethyl cellulose. Drug content was determined by UV spectroscopy and dispensing precision from printed disc mass. Results: Mean felodipine content was within ±5% of target values for all print volumes and compositions including contents as high as ~50% w/w. However, poor dispensing precision was evident at all print volumes. Conclusions: In pursuit of dose flexibility, this successful demonstration of dose window extension using high content solid dispersions preserves FDM design flexibility by maintaining applicability to drugs of varying potencies. The achieved uniformity of content supports the application of varying content solid dispersions to modular dosage form concepts to enhance dose flexibility. However, poor dispensing precision impedes its utilisation until appropriate compatibility between FDM hardware and materials at varying drug contents can be attained.

modular design

fused deposition modelling

uniformity of drug content

solid dispersion

dose flexibility

Författare

Rydvikha Govender

AstraZeneca AB

Chalmers, Kemi och kemiteknik, Tillämpad kemi, Anette Larsson Group

Susanna Abrahmsén-Alami

AstraZeneca AB

Staffan Folestad

AstraZeneca AB

Anette Larsson

Chalmers, Kemi och kemiteknik, Tillämpad kemi, Anette Larsson Group

Pharmaceutical Research

0724-8741 (ISSN) 1573-904X (eISSN)

Vol. 37 1 9

Ämneskategorier

Medieteknik

Polymerkemi

Farmaceutisk vetenskap

DOI

10.1007/s11095-019-2720-6

PubMed

31848730

Mer information

Senast uppdaterat

2020-01-24