Tags

Type your tag names separated by a space and hit enter

Effects of spray drying process parameters on the solubility behavior and physical stability of solid dispersions prepared using a laboratory-scale spray dryer.
Drug Dev Ind Pharm. 2013 Sep; 39(9):1484-93.DD

Abstract

PURPOSE

The purpose of this study is to determine the process parameters of the laboratory-scale spray dryer affecting the solubility behavior and physical stability of solid dispersions.

METHODS

Solid dispersions of the model drug (nilvadipine or nifedipine) and hypromellose (HPMC) (w/w: 1/1) were prepared using the laboratory-scale spray dryer. As process parameters, nitrogen flow rate, sample concentration and pump speed were investigated. The samples were characterized by dissolution tests, powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), scanning electron microscope (SEM), and nanoscale thermal analysis (Nano-TA). The physical stability was monitored after 7 months storage at 25°C.

RESULTS

Solubility behavior and physical stability were improved by setting the low nitrogen flow rate and high sample concentration. DSC showed that the physical state depends on the spray drying conditions, whereas, every sample showed the similar morphology from SEM results. The difference of solubility behavior and physical stability were found to come from the microstructural phase separation of the spray dried particles using a novel analytical technique (Nano-TA).

CONCLUSIONS

This study demonstrated that nitrogen flow rate and sample concentration should be the critical parameters for the enhancements of the solubility and physical stability of solid dispersions.

Authors+Show Affiliations

Production Engineering Department, Chugai Pharmaceutical Co., Ltd., Kita-ku, Tokyo, Japan. kojimayuk@chugai-pharm.co.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22670826

Citation

Kojima, Yuki, et al. "Effects of Spray Drying Process Parameters On the Solubility Behavior and Physical Stability of Solid Dispersions Prepared Using a Laboratory-scale Spray Dryer." Drug Development and Industrial Pharmacy, vol. 39, no. 9, 2013, pp. 1484-93.
Kojima Y, Ohta T, Shiraki K, et al. Effects of spray drying process parameters on the solubility behavior and physical stability of solid dispersions prepared using a laboratory-scale spray dryer. Drug Dev Ind Pharm. 2013;39(9):1484-93.
Kojima, Y., Ohta, T., Shiraki, K., Takano, R., Maeda, H., & Ogawa, Y. (2013). Effects of spray drying process parameters on the solubility behavior and physical stability of solid dispersions prepared using a laboratory-scale spray dryer. Drug Development and Industrial Pharmacy, 39(9), 1484-93. https://doi.org/10.3109/03639045.2012.692378
Kojima Y, et al. Effects of Spray Drying Process Parameters On the Solubility Behavior and Physical Stability of Solid Dispersions Prepared Using a Laboratory-scale Spray Dryer. Drug Dev Ind Pharm. 2013;39(9):1484-93. PubMed PMID: 22670826.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of spray drying process parameters on the solubility behavior and physical stability of solid dispersions prepared using a laboratory-scale spray dryer. AU - Kojima,Yuki, AU - Ohta,Tomoaki, AU - Shiraki,Kouji, AU - Takano,Ryusuke, AU - Maeda,Hiroyuki, AU - Ogawa,Yutaka, Y1 - 2012/06/07/ PY - 2012/6/8/entrez PY - 2012/6/8/pubmed PY - 2013/12/16/medline SP - 1484 EP - 93 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 39 IS - 9 N2 - PURPOSE: The purpose of this study is to determine the process parameters of the laboratory-scale spray dryer affecting the solubility behavior and physical stability of solid dispersions. METHODS: Solid dispersions of the model drug (nilvadipine or nifedipine) and hypromellose (HPMC) (w/w: 1/1) were prepared using the laboratory-scale spray dryer. As process parameters, nitrogen flow rate, sample concentration and pump speed were investigated. The samples were characterized by dissolution tests, powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), scanning electron microscope (SEM), and nanoscale thermal analysis (Nano-TA). The physical stability was monitored after 7 months storage at 25°C. RESULTS: Solubility behavior and physical stability were improved by setting the low nitrogen flow rate and high sample concentration. DSC showed that the physical state depends on the spray drying conditions, whereas, every sample showed the similar morphology from SEM results. The difference of solubility behavior and physical stability were found to come from the microstructural phase separation of the spray dried particles using a novel analytical technique (Nano-TA). CONCLUSIONS: This study demonstrated that nitrogen flow rate and sample concentration should be the critical parameters for the enhancements of the solubility and physical stability of solid dispersions. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/22670826/Effects_of_spray_drying_process_parameters_on_the_solubility_behavior_and_physical_stability_of_solid_dispersions_prepared_using_a_laboratory_scale_spray_dryer_ L2 - http://www.tandfonline.com/doi/full/10.3109/03639045.2012.692378 DB - PRIME DP - Unbound Medicine ER -