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Literature DB >> 7494814

Pharmaceutical solids: a strategic approach to regulatory considerations.

S Byrn¹, R Pfeiffer, M Ganey, C Hoiberg, G Poochikian.

Abstract

PURPOSE: This review describes a conceptual approach to the characterization of pharmaceutical solids.
METHODS: Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms.
RESULTS: These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes.
CONCLUSIONS: It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.

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Year: 1995 PMID： 7494814 DOI： 10.1023/a:1016241927429

Source DB: PubMed Journal: Pharm Res ISSN： 0724-8741 Impact factor: 4.200

12 in total

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Journal: J Pharm Sci Date: 1963-08 Impact factor: 3.534

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Journal: J Pharm Sci Date: 1963-02 Impact factor: 3.534

3. Physicochemical properties of crystalline forms of ethynylestradiol solvates: comparison of thermal behavior with X-ray crystal structure.

Authors: T Ishida; M Doi; M Shimamoto; N Minamino; K Nonaka; M Inoue
Journal: J Pharm Sci Date: 1989-04 Impact factor: 3.534

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Journal: J Pharm Sci Date: 1969-08 Impact factor: 3.534

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Authors: E Fukuoka; M Makita; S Yamamura
Journal: Chem Pharm Bull (Tokyo) Date: 1986-10 Impact factor: 1.645

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Authors: P J Saindon; N S Cauchon; P A Sutton; C J Chang; G E Peck; S R Byrn
Journal: Pharm Res Date: 1993-02 Impact factor: 4.200

Review 7. Solid-state nuclear magnetic resonance spectroscopy: theory and pharmaceutical applications.

Authors: D E Bugay
Journal: Pharm Res Date: 1993-03 Impact factor: 4.200

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Authors: Y Matsuda; E Tatsumi; E Chiba; Y Miwa
Journal: J Pharm Sci Date: 1984-10 Impact factor: 3.534

9. Fenoprofen: drug form selection and preformulation stability studies.

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Journal: J Pharm Sci Date: 1978-02 Impact factor: 3.534

10. X-ray crystallographic characterization of two polymorphs of 8-(2-methoxycarbonylamino-6-methylbenzyloxy)-2-methyl-3-(2- propynyl)-imidazo [1,2-a]pyridine.

Authors: A Miyamae; S Koda; S Kitamura; Y Okamoto; Y Morimoto
Journal: J Pharm Sci Date: 1990-03 Impact factor: 3.534

39 in total

1. Quantitative correlation between initial dissolution rate and heat of solution of drug.

Authors: K Terada; H Kitano; Y Yoshihashi; E Yonemochi
Journal: Pharm Res Date: 2000-08 Impact factor: 4.200

2. What is the true solubility advantage for amorphous pharmaceuticals?

Authors: B C Hancock; M Parks
Journal: Pharm Res Date: 2000-04 Impact factor: 4.200

Review 3. Diamonds in the rough: protein crystals from a formulation perspective.

Authors: A Jen; H P Merkle
Journal: Pharm Res Date: 2001-11 Impact factor: 4.200

4. Investigation of solid-state reactions using variable temperature X-ray powder diffractometry. II. Aminophylline monohydrate.

Authors: Suneel K Rastogi; Marek Zakrzewski; Raj Suryanarayanan
Journal: Pharm Res Date: 2002-09 Impact factor: 4.200

Review 5. Differential scanning calorimetry techniques: applications in biology and nanoscience.

Authors: Pooria Gill; Tahereh Tohidi Moghadam; Bijan Ranjbar
Journal: J Biomol Tech Date: 2010-12

6. Investigation of the multi-step dehydration reaction of theophylline monohydrate using 2-dimensional powder X-ray diffractometry.

Authors: Cletus Nunes; Arumugam Mahendrasingam; Raj Suryanarayanan
Journal: Pharm Res Date: 2006-09-01 Impact factor: 4.200

7. The role of molecular structure in the crystal polymorphism of local anesthetic drugs: crystal polymorphism of local anesthetic drugs, part X.

Authors: Andrea C Schmidt
Journal: Pharm Res Date: 2005-11-16 Impact factor: 4.200

8. Quantification of crystallinity in substantially amorphous materials by synchrotron X-ray powder diffractometry.

Authors: Cletus Nunes; Arumugam Mahendrasingam; Raj Suryanarayanan
Journal: Pharm Res Date: 2005-08-31 Impact factor: 4.200

9. Influence of Hydroxypropyl Methylcellulose on Metronidazole Crystallinity in Spray-Congealed Polyethylene Glycol Microparticles and Its Impact with Various Additives on Metronidazole Release.

Authors: Ching Mien Oh; Paul Wan Sia Heng; Lai Wah Chan
Journal: AAPS PharmSciTech Date: 2015-05-02 Impact factor: 3.246

10. Particle size dependent molecular rearrangements during the dehydration of trehalose dihydrate in situ FT-Raman spectroscopy.

Authors: L S Taylor; A C Williams; P York
Journal: Pharm Res Date: 1998-08 Impact factor: 4.200