Formulation analyses of high-volume prescription drugs

A collection of 65 formulated tablets and capsules were analyzed for phase composition by full pattern matching powder diffraction methods. The collection contained 32 of the top 200 prescription drugs sold in 2016 as well as many high-volume prescriptions and over the counter drugs from prior years...

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Bibliographic Details
Published inPowder diffraction Vol. 34; no. 2; pp. 130 - 142
Main Authors Fawcett, T.G., Gates-Rector, S., Gindhart, A.M., Rost, M., Kabekkodu, S.N., Blanton, J. R., Blanton, T. N.
Format Journal Article
LanguageEnglish
Published New York, USA Cambridge University Press 01.06.2019
Subjects
Allergies
Analgesics
Antibiotics
Anticoagulants
Blood pressure
Cellulose
Cholesterol
Coherent scattering
Collection
Constipation
Datasets
Dementia
Diabetes
Diffraction patterns
Drugs
Excipients
Formulations
Gastroesophageal reflux
Incoherent scattering
Ingredients
Laboratories
Lactose
Low concentrations
Methods
Narcotics
Pain
Pattern matching
Pharmaceuticals
Phase composition
Prescription drugs
Software
Tablets
Technical Article
United States > US
pharmaceutical
amorphous
formulations
powder diffraction
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Summary:A collection of 65 formulated tablets and capsules were analyzed for phase composition by full pattern matching powder diffraction methods. The collection contained 32 of the top 200 prescription drugs sold in 2016 as well as many high-volume prescriptions and over the counter drugs from prior years. The study was used to evaluate new methods of analysis as well as the efficacy of programs designed to collect references on high volume excipients and pharmaceuticals for inclusion in the Powder Diffraction File™. The use of full pattern matching methods as well as reference pattern additions of many common excipients enabled major phase excipient identification in all formulations. This included identification of crystalline, nanocrystalline, and amorphous ingredients because full pattern matching involved the use of characteristic coherent and incoherent scatter. Oftentimes identification of the major excipients significantly aided the clean identification of the active pharmaceutical ingredients (APIs) and their polymorphic form, even at low concentrations (1–10 wt. %). Overall 93% of the APIs were identified, most through a PDF® material reference, but also through patent cross-referencing and similarity analysis comparisons.
ISSN:0885-7156
1945-7413
DOI:10.1017/S0885715619000253