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Continuous low-dose feeding of highly active pharmaceutical ingredients in hot-melt extrusion.
Drug Dev Ind Pharm. 2016 Aug; 42(8):1360-4.DD

Abstract

CONTEXT

Manufacturing solid low-dose pharmaceutical products has always the homogeneity challenge. In continuous manufacturing, there is the additional challenge of feeding active pharmaceutical ingredient (API) dry powder at low rates. This paper presents a method for feeding API particles into a continuous extrusion process using a suspension. The challenges for feeding and the product homogeneity are both addressed.

OBJECTIVE

The objective of this study is to demonstrate the feasibility of manufacturing low-dose extrudates by feeding the API particles in a diluted anti-solvent suspension.

MATERIALS AND METHODS

Extrudates with an Ibuprofen content of 0.021% and 0.043% (w/w) were prepared by feeding a 0.9% w/w suspension of Ibuprofen particles into a Coperion extruder.

RESULTS AND DISCUSSION

The homogeneity (RSD) of extrudates was tested during a time span of 30 min and had values between 2% and 7%.

CONCLUSION

Feeding particles in an anti-solvent suspension offers a simple feeding option for API and minor components which yield products of desired homogeneity. The liquid feeding approach offers a simplified process with enhanced process control possibilities.

Authors+Show Affiliations

a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ;a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ;a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ;a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ;a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ;a Research Center Pharmaceutical Engineering GmbH , Graz , Austria ; b Institute for Particle and Process Engineering , Graz University of Technology , Graz , Austria.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26755129

Citation

Llusa, Marcos, et al. "Continuous Low-dose Feeding of Highly Active Pharmaceutical Ingredients in Hot-melt Extrusion." Drug Development and Industrial Pharmacy, vol. 42, no. 8, 2016, pp. 1360-4.
Llusa M, Mohr S, Baumgartner R, et al. Continuous low-dose feeding of highly active pharmaceutical ingredients in hot-melt extrusion. Drug Dev Ind Pharm. 2016;42(8):1360-4.
Llusa, M., Mohr, S., Baumgartner, R., Paudel, A., Koscher, G., & Khinast, J. (2016). Continuous low-dose feeding of highly active pharmaceutical ingredients in hot-melt extrusion. Drug Development and Industrial Pharmacy, 42(8), 1360-4. https://doi.org/10.3109/03639045.2015.1135938
Llusa M, et al. Continuous Low-dose Feeding of Highly Active Pharmaceutical Ingredients in Hot-melt Extrusion. Drug Dev Ind Pharm. 2016;42(8):1360-4. PubMed PMID: 26755129.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous low-dose feeding of highly active pharmaceutical ingredients in hot-melt extrusion. AU - Llusa,Marcos, AU - Mohr,Stefan, AU - Baumgartner,Ramona, AU - Paudel,Amrit, AU - Koscher,Gerold, AU - Khinast,Johannes, Y1 - 2016/01/24/ PY - 2016/1/13/entrez PY - 2016/1/13/pubmed PY - 2017/3/25/medline KW - API homogeneity KW - continuous manufacturing KW - hot-melt extrusion KW - liquid feeding KW - low-dose solid products SP - 1360 EP - 4 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 42 IS - 8 N2 - CONTEXT: Manufacturing solid low-dose pharmaceutical products has always the homogeneity challenge. In continuous manufacturing, there is the additional challenge of feeding active pharmaceutical ingredient (API) dry powder at low rates. This paper presents a method for feeding API particles into a continuous extrusion process using a suspension. The challenges for feeding and the product homogeneity are both addressed. OBJECTIVE: The objective of this study is to demonstrate the feasibility of manufacturing low-dose extrudates by feeding the API particles in a diluted anti-solvent suspension. MATERIALS AND METHODS: Extrudates with an Ibuprofen content of 0.021% and 0.043% (w/w) were prepared by feeding a 0.9% w/w suspension of Ibuprofen particles into a Coperion extruder. RESULTS AND DISCUSSION: The homogeneity (RSD) of extrudates was tested during a time span of 30 min and had values between 2% and 7%. CONCLUSION: Feeding particles in an anti-solvent suspension offers a simple feeding option for API and minor components which yield products of desired homogeneity. The liquid feeding approach offers a simplified process with enhanced process control possibilities. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/26755129/Continuous_low_dose_feeding_of_highly_active_pharmaceutical_ingredients_in_hot_melt_extrusion_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2015.1135938 DB - PRIME DP - Unbound Medicine ER -