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.

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.

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

scholarly journals Recent Advanced of Multiple Unite Pellet System (MUPS) Technology in Formulation of Pharmaceutical Products: A Review

2020 ◽  
Vol 9 (10) ◽  
pp. 20202-20214
Author(s):  
V. K . Chatap ◽  
Deshbandhu Joshi
Keyword(s):  
Oral Route ◽  
Pharmaceutical Products ◽  
Active Pharmaceutical Ingredients ◽  
Blood Profile ◽  
Pharmaceutical Ingredients ◽  
Solid Dosage ◽  
Drug Substances ◽  
Form Design ◽  
Multiple Unit ◽  
User Friendly

The oral route of drug administration is the most important and most user-friendly route of administration. In recent years, Multiple Unit Pellet Systems (MUPS) tablets are widely used in solid dosage form design. MUPS is considered to provide pharmacokinetic advantages compared to monolithic dosage forms. Combination of drug substances and release profiles can be provided by formulating the MUPS tablets with different pellet qualities or combining pellets with drugs in powder or granulated form. MUPS tablet contains several hundred of coated pellets of active pharmaceutical ingredients which delivered the drug at predetermined rate and absorption to provide constant blood profile. MUPS are easily administered as disintegratable tablet which disperse into their subunits across the stomach and the small intestine, leading to predictable oral transition and constant bioavailability.

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