scholarly journals Characterization of Tableting Speed-Dependent Deformation Properties of Active Pharmaceutical Ingredients in Powder Mixtures Using Out-of-Die Method

2021 ◽  
Vol 69 (12) ◽  
pp. 1184-1194
Author(s):  
Daisuke Mizunaga ◽  
Mika Koseki ◽  
Naoki Kamemoto ◽  
Satoru Watano
Keyword(s):  
Active Pharmaceutical Ingredients ◽  
Powder Mixtures ◽  
Pharmaceutical Ingredients ◽  
Deformation Properties

scholarly journals Assay and physicochemical characterization of the antiparasitic albendazole

2012 ◽  
Vol 48 (2) ◽  
pp. 281-290 ◽  
Author(s):  
Noely Camila Tavares Cavalcanti ◽  
Giovana Damasceno Sousa ◽  
Maria Alice Maciel Tabosa ◽  
José Lamartine Soares Sobrinho ◽  
Leila Bastos Leal ◽  
...  
Keyword(s):  
Physicochemical Characterization ◽  
Analytical Techniques ◽  
Assay Method ◽  
Active Pharmaceutical Ingredients ◽  
X Ray Diffraction ◽  
Melting Points ◽  
X Ray ◽  
Pharmaceutical Ingredients ◽  
Complementary Techniques

The aim of this study was to characterize three batches of albendazole by pharmacopeial and complementary analytical techniques in order to establish more detailed specifications for the development of pharmaceutical forms. The ABZ01, ABZ02, and ABZ03 batches had melting points of 208 ºC, 208 ºC, and 209 ºC, respectively. X-ray diffraction revealed that all three batches showed crystalline behavior and the absence of polymorphism. Scanning electron microscopy showed that all the samples were crystals of different sizes with a strong tendency to aggregate. The samples were insoluble in water (5.07, 4.27, and 4.52 mg mL-1, respectively) and very slightly soluble in 0.1 M HCl (55.10, 56.90, and 61.70 mg mL-1, respectively) and additionally showed purities within the range specified by the Brazilian Pharmacopoeia 5th edition (F. Bras. V; 98% to 102%). The pharmacopeial assay method was not reproducible and some changes were necessary. The method was validated and showed to be selective, specific, linear, robust, precise, and accurate. From this characterization, we concluded that pharmacopeial techniques alone are not able to detect subtle differences in active pharmaceutical ingredients; therefore, the use of other complementary techniques is required to ensure strict quality control in the pharmaceutical industry.

scholarly journals Characterization of Potentized (Homeopathic, Anthroposophical and Antihomotoxic) Medicines Registered and Notified In Brazil

2021 ◽  
Vol 14 (3) ◽  
pp. 20-35
Author(s):  
Robelma Frande de Oliveira Marques ◽  
Ana Cecília Bezerra Carvalho ◽  
Marco Antonio Costa
Keyword(s):  
Oral Route ◽  
Health Surveillance ◽  
Manufacturing Processes ◽  
Active Pharmaceutical Ingredients ◽  
Regulatory Activity ◽  
Registration System ◽  
Pharmaceutical Ingredients ◽  
Industry Sector ◽  
Brazilian Legislation

Background: Potentized medicines include, according to the Brazilian legislation, homeopathic, anthroposophic, and antihomotoxic medicine and are regulated by the Brazilian Health Surveillance Agency (ANVISA). Aim: This study aims to analyze and describe a profile of potentized medicines manufactured in Brazil, either registered or notified. Methodology: Information was obtained by data analysis related to ANVISA’s electronic medicine registration system. Results: The results, obtained as of September 2012, showed that 106 potentized medicines were registered and 519 were notified. Among the registered medicines, 92.0% were combined and 100.0% of the notified were simple medicines. For registered medicines, there were equivalent manufacturing scales among them, whereas for notified medicines, there was a predominance of centesimal scales. Active pharmaceutical ingredients (API’s) of vegetal origin were the most commonly used for potentized medicine manufacturing processes; the oral route was the most common form of administration. Potentized medicines manufacturing units are more often located in southeast region of Brazil. In addition, homeopathic medicines prevail as registered or notified medicines, followed by anthroposophic medicines. Conclusions: The results of the study are expected to be useful as reference material for ANVISA to improve its regulatory activity as well the industry sector and other stakeholders.

Polymorph Characterization of Active Pharmaceutical Ingredients (APIs) Using Low-Frequency Raman Spectroscopy

2014 ◽  
Vol 68 (7) ◽  
pp. 758-776 ◽  
Author(s):  
Peter J. Larkin ◽  
Marta Dabros ◽  
Beth Sarsfield ◽  
Eric Chan ◽  
James T. Carriere ◽  
...  
Keyword(s):  
Raman Spectroscopy ◽  
Low Frequency ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients

Raman and Terahertz Spectroscopic Characterization of Solid-state Cocrystal Formation within Specific Active Pharmaceutical Ingredients

2020 ◽  
Vol 26 (38) ◽  
pp. 4829-4846
Author(s):  
Yong Du ◽  
Jiadan Xue ◽  
Zhi Hong
Keyword(s):  
Solid State ◽  
Drug Research ◽  
Terahertz Spectroscopy ◽  
Spectroscopic Characterization ◽  
Time Dependent ◽  
Active Pharmaceutical Ingredients ◽  
Covalent Bonds ◽  
Pharmaceutical Ingredients ◽  
Kinetic Information

: Cocrystallization of specific active pharmaceutical ingredients (APIs) in the solid-state phase is becoming a feasible way to improve their corresponding physicochemical properties and ultimate bioavailability without making and breaking any covalent bonds within them. Many recent reports deal with the characterization and analysis topics of pharmaceutical APIs-based cocrystals. In this mini-review, we will focus on the recent steady-state and time-dependent spectroscopic investigation into the cocrystallization of specific APIs based on both Raman and emerging terahertz spectroscopy in pharmaceutical fields. Distinctive spectral, structural and also kinetic information of pharmaceutical APIs-based cocrystals are obtained and discussed, which would highlight the potential of vibrational spectroscopy as an attractive technique for various drug research and development during cocrystallization of specific APIs.

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