scholarly journals POLYMORPHISM AND POLYMORPH CHARACTERISATION IN PHARMACEUTICALS

2019 ◽  
Vol 8 (5) ◽  
Author(s):  
Dr Amit Gosar ◽  
Dr Sayyed Hussain ◽  
Dr Tabrez Shaikh
Keyword(s):  
Drug Product ◽  
Analytical Techniques ◽  
Spectroscopic Properties ◽  
Crystalline Form ◽  
Kinetic Properties ◽  
Specific Chemical ◽  
Safety And Efficacy ◽  
Drug Products ◽  
Drug Substances ◽  
The Given

Polymorphism is the ability of a specific chemical compound to crystallize in more than one crystalline form. Polymorphs had a different arrangement of the molecule in the given crystal lattice and  may properties such as packing properties, thermodynamic properties, spectroscopic properties, kinetic properties, surface properties and mechanical properties. Polymorph can be classified in various class such as crystalline, amorphous, hydrate and solvate. Polymorphs are categorized into two types, enantiotropes and monotropes, depending upon their stability with respect to the range of temperatures and pressures. There are various guidelines for the control of polymorphs in drug substances and drug product. Different analytical techniques are used for the detection, quantification and characterisation of the polymorphs in the drug substances and drug products. Control of polymorph in a drug substance and drug product is important for the safety and efficacy of the drug. Keywords: Polymorphism, classification, guidelines, characterisation, drug substances.

Accelerating pre-formulation investigations in early drug product lifecycle using predictive methodologies and computational algorithms

2021 ◽  
Author(s):  
Harsh S Shah ◽  
Kaushalendra Chaturvedi ◽  
Shanming Kuang ◽  
Jian Wang
Keyword(s):  
Case Studies ◽  
Drug Product ◽  
Analytical Techniques ◽  
Cost Effective ◽  
Product Lifecycle ◽  
Predictive Tools ◽  
Drug Products ◽  
Current Trends ◽  
Drug Substances ◽  
Early Drug

Precisely developed computational methodologies can allow the drug product lifecycle process to be time-efficient, cost-effective and reliable through a thorough fundamental understanding at the molecular level. Computational methodologies include computational simulations, virtual screening, mathematical modeling and predictive tools. In light of current trends and increased expectations of product discovery in early pharmaceutical development, we have discussed different case studies. These case studies clearly demonstrate the successful application of predictive tools alone or in combination with analytical techniques to predict the physicochemical properties of drug substances and drug products, thereby shortening research and development timelines. The overall goal of this report is to summarize unique predictive methodologies, which can assist pharmaceutical scientists in achieving time-sensitive research goals and avoiding associated risks that can potentially affect the drug product quality.

scholarly journals Innovative methodologies for identification and qualification of Impurities: An overview of the latest trends on impurity profiling

2020 ◽  
Vol 11 (3) ◽  
pp. 2909-2921
Author(s):  
Nishanth G ◽  
Akhila G ◽  
Anandkumar Tengli ◽  
Chandan R S ◽  
Suraj K ◽  
...  
Keyword(s):  
Pharmaceutical Research ◽  
Analytical Techniques ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Analytical Methodology ◽  
Drug Products ◽  
Technical Developments ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Bulk Drug

Impurity profiling is known to identify, classify and measure both the identified and non-identified contamination present on the medicinal product. Unwanted chemicals which remain or are created during the formulation of medicinal products are pharmaceutical impurities. Impurity profiling helps in the detection, recognition and quantification in bulk products and pharmaceutical formulations of various types of impurities, as well as residual solvents. It is the simplest way to distinguish consistency and stability of bulk drugs and medication formulations. As analytical methodology has developed rapidly, it is essential to consider with their solutions problems related to impurities of drug substances and drug products. Various regulatory agencies including ICH, USFDA, Canadian Drug and Health Agencies stress the criteria for purity and for detecting impurities in active pharmaceutical materials, even in small quantities, as the presence of impurities, may have an effect on pharmaceutical products ’ efficacy and health. Therefore, the study focuses on various analytical methods for identification and quantification of impurities in pharmaceutical products to clarify the need for impurity profiling on drug products in pharmaceutical research. To drug regulators, the product substance’s impurity profile is a reliable fingerprint to prove that the manufacturing process of bulk drug substances is consistent in quality. The study gives a short summary of recent technical developments in the profiling of pharmaceutical products including pharmaceutical active ingredients as well as pharmaceutical products during 2013-2017. Such recent trends in the profiling of impurities have been addressed in the study. This focuses specifically on a thorough update on various analytical techniques, including hyphenated methods to define and measure thresholds in specific pharmaceutical matrices of impurities and degradants.

Investigation of the effect of loratadine and calcium ions on oxidoreductase activity of catalase enzyme

2020 ◽  
Vol 16 ◽  
Author(s):  
Edhem Hasković ◽  
Safija Herenda ◽  
Zehra Halilović ◽  
Snežana Unčanin ◽  
Denis Hasković ◽  
...  
Keyword(s):  
Calcium Ions ◽  
Enzyme Reaction ◽  
Analytical Techniques ◽  
Competitive Inhibitor ◽  
Cellular Functions ◽  
Oxidoreductase Activity ◽  
H1 Antihistamines ◽  
Activity Of Enzymes ◽  
The Given

Background: The Spectrophotometric method is one of the most suitable analytical techniques for testing the activity of enzymes under the influence of various factors. Methods: The effect of H1-antihistamines of loratadine and calcium ions on enzyme catalase under in vitro conditions was investigated in this paper. Results and Discussion: It has been shown that loratadine isa partial inhibitor of catalase, but this effect is diminished in the presence of calcium ions. Calcium as well as other cations are important for many biological and cellular functions. The kidneys play a central role in the homeostasis of these ions. The activity of the catalase enzyme under the given conditions, the type of inhibition,and the kinetic parameters of the enzyme reaction were determined. Conclusion: We concluded that loratadine is a partially competitive inhibitor.

Thermal Decomposition of Vulcanized Structures of Deformed Vulcanizates Containing Various Accelerators

1953 ◽  
Vol 26 (4) ◽  
pp. 759-763 ◽  
Author(s):  
B. Dogadkin ◽  
Z. Tarasova
Keyword(s):  
Stress Relaxation ◽  
Physical And Mechanical Properties ◽  
Heat Stability ◽  
Chemical Bonds ◽  
Structural Elements ◽  
Specific Chemical ◽  
Vulcanized Rubber ◽  
Different Temperatures ◽  
Chemical Groups ◽  
The Given

Abstract According to the hypotheses developed by the authors, vulcanized rubber is a system in which the molecular chains are united by local molecular and chemical bonds of varying intensity. The concentration, distribution, and strength of these bonds determine the principal physical and mechanical properties of the vulcanizates. Consequently the study of the structure of the vulcanizate is of primary practical value. The explanation of the nature of the bonds in a vulcanizate by chemical methods is very difficult, mainly because of the impossibility of distinguishing the specific chemical groups which enter into the composition of the different molecular chains from those bonds between the chains which are responsible for the development of spatial structures. From this view point, the thermo-mechanical method described below, which is based on the study of stress relaxation at different temperatures, is of great significance. As was shown by Dogadkin and Reznikovskii˘, the delayed stress relaxation in a vulcanizate at temperatures up to 70° C is caused by rupture of the local intermolecular bonds and the regrouping of the structural elements of the polymeric chains without destruction of the chemical bonds between them. Accordingly, after some time at these temperatures, a practically balanced stress is established, which depends on the number of the stronger bonds remaining. At temperatures above 70° C, rupture of the chemical bonds between the chains takes place; its speed increases with decrease of the energy activating the rupture of the given type of bond. Particularly in the case of sulfur vulcanizates, we can assume that the following types of bonds exist between the chains of the rubber: (1) —C—C—, which develop as a result of the polymerizationprocesses; (2) —C—S—C— monosulfide; (3) —C—S—S—C— disulfide, and (4) —C—Sn—C— polysulfide, formed as a result of the direct participation of the vulcanizing agent, sulfur, in the process of joining of the molecular chains. The energy of these chains can be estimated as 62.7 kcal, per mole for C—C, 54.5 kcal. per mole for C—S, and 27.5 kcal. per mole for the —S—S bond. Naturally, the heat stability of a vulcanizate will depend on which of the indicated types of bonds predominates.

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

scholarly journals Rapid microbiological testing method

2020 ◽  
Vol 11 (3) ◽  
pp. 3927-3932
Author(s):  
Raghuprakash P ◽  
Gowrav M P ◽  
Gangadharappa H V ◽  
Hemanth Kumar S
Keyword(s):  
Clinical Laboratory ◽  
Drug Product ◽  
Free Products ◽  
Hygienic Condition ◽  
Cycle Times ◽  
Drug Products ◽  
Microbiological Methods ◽  
Wide Range ◽  
Microbiological Testing ◽  
Microorganism Identification

Classical microbiological methods currently have unacceptably long cycle times. Rapid microbiological strategies are accessible within the marketplace for about 10 years and are mostly used in the clinical laboratory and in food industries. However, their reapplication in the pharma industry has wide range of advantage. A comparison with ancient strategies to be conjointly performed. During this review, data concerning the validation of RMM strategies described within the document was given in addition as proof of the issue of validation of those strategies. A comparison with ancient strategies is additionally mentioned. This data is beneficial to the industries and in the labs which will doubtless be adopted. These strategies for microorganism free products. This methodology for microorganism identification will be delicate, accurate and fast. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained. This article also includes different methods for identifying bacteria which is present in drug products as well as the material which are used for doing test. Presence of bacteria may affect the activity of drug product and bio availability may decreases and potency the drug may loss. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained.

scholarly journals Liposome Characterization, Applications and Regulatory landscape in US

2021 ◽  
Vol 9 (2) ◽  
pp. 81-89
Author(s):  
Amit Kumar ◽  
Madhu Gupta ◽  
Simran Braya
Keyword(s):  
Drug Product ◽  
Drug Carrier ◽  
Current Status ◽  
Liposomal Drug ◽  
Drug Products ◽  
Target Drug Delivery ◽  
Target Drug ◽  
Conventional Drug ◽  
Regulatory Guidelines ◽  
Reduced Toxicity

Liposomes are lipid based drug carrier whose therapeutic performance depends on their structure. Liposomes offer several advantages over the conventional drug like target drug delivery, reduced toxicity, and extended pharmacokinetics. Characterization and Identification of critical attribute of liposomal formulation and suitable strategies for control during product development is important for quality of the liposomal drug product. This paper discusses the current status of the liposomal drug product and strategy used in regulating liposome product. Despite of lack of regulatory guidelines many liposome formulations get approved which shows the potential of liposome drug products.

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