scholarly journals Model-Based Tools for Pharmaceutical Manufacturing Processes

Processes ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 49 ◽  
Author(s):  
René Schenkendorf ◽  
Dimitrios Gerogiorgis ◽  
Seyed Mansouri ◽  
Krist Gernaey
Keyword(s):  
Quality Control ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Processes ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Model Based ◽  
Production Processes ◽  
Highly Sensitive

Active pharmaceutical ingredients (APIs) are highly valuable, highly sensitive products resulting from production processes with strict quality control specifications and regulations that are required for the safety of patients [...]

Chemometric approaches to low-content quantification (LCQ) in solid-state mixtures using Raman mapping spectroscopy

2017 ◽  
Vol 9 (44) ◽  
pp. 6293-6301 ◽  
Author(s):  
Boyan Li ◽  
Yannick Casamayou-Boucau ◽  
Amandine Calvet ◽  
Alan G. Ryder
Keyword(s):  
Solid State ◽  
Pharmaceutical Manufacturing ◽  
Active Pharmaceutical Ingredients ◽  
Raman Mapping ◽  
Pharmaceutical Ingredients

The low-content quantification (LCQ) of active pharmaceutical ingredients or impurities in solid mixtures is important in pharmaceutical manufacturing and analysis.

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.

Fractal Analysis of Lyophilized Active Pharmaceutical Ingredients

2020 ◽  
Vol 36 (5) ◽  
pp. 98-103
Author(s):  
I.A. Selivanova
Keyword(s):  
Quality Control ◽  
Fractal Analysis ◽  
Fractal Geometry ◽  
Pharmaceutical Analysis ◽  
Bifidobacterium Bifidum ◽  
Academic Excellence ◽  
Control Methods ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Rapid Tests

The development of effective drug quality control methods based on intelligent technologies is an urgent task for pharmaceutical analysis in the context of production robotization. This is particularly topical for biotechnology-derived pharmaceutical ingredients due to the peculiarities of the analysis of these compounds and limited number of quality control methods for drugs. Fractal geometry can be a mathematical background for the creation of such method. In this work we studied the possibility of fractal geometry using for the development of rapid tests for bifidumbacterin lyophilisates. A correlation was established between the fractal dimension of the structure of the Bifidobacterium bifidum dry mixture solids with sucrose-gelatin-milk medium and the specified pharmaceutical ingredient parameters, such as drug reconstitution time (R2=0,97) and pH (R2=0,95). This work demonstrated that fractal analysis is a promising tool for automated rapid tests of lyophilized biotechnology-derived active pharmaceutical ingredients without losing the analyzed sample. fractal analysis, pharmaceutical analysis, quality control, lyophilisates, bifidumbacterin. This work was supported by the Russian Academic Excellence Project 5-100

scholarly journals Quality Control in Automated Manufacturing Processes – Combined Features for Image Processing

10.14311/868 ◽  
2006 ◽  
Vol 46 (5) ◽  
Author(s):  
B. Kuhlenkötter ◽  
X. Zhang ◽  
C. Krewet
Keyword(s):  
Image Processing ◽  
Quality Control ◽  
Support Vector ◽  
Manufacturing Processes ◽  
Automated Manufacturing ◽  
Defect Classification ◽  
Production Processes ◽  
Combined Features ◽  
Important Challenge ◽  
Selection Of

In production processes the use of image processing systems is widespread. Hardware solutions and cameras respectively are available for nearly every application. One important challenge of image processing systems is the development and selection of appropriate algorithms and software solutions in order to realise ambitious quality control for production processes. This article characterises the development of innovative software by combining features for an automatic defect classification on product surfaces. The artificial intelligent method Support Vector Machine (SVM) is used to execute the classification task according to the combined features. This software is one crucial element for the automation of a manually operated production process. 

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