scholarly journals Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients

2018 ◽  
Vol 6 (3) ◽  
pp. 69-74
Author(s):  
Priyanka D Debaje ◽  
Gurmeet S. Chhabra ◽  
Nayan Gujarathi
Keyword(s):  
Raw Materials ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Cleaning Validation ◽  
Cleaning Agents ◽  
Predetermined Level ◽  
Extraneous Material

 Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust,  lubricants, raw materials,  intermediates, etc. In the manufacturing of the pharmaceutical products, it is a must to reproduce consistently the desired quality of product. Residual material from the previous batch of the same product or from different product may be carried to the next batch of the product, which in turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning method employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level The purpose of this review is to provide information about importance of cleaning validation of API in pharmaceutical industry and this information is in accordance with the regulatory guidelines

US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain

2021 ◽  
pp. 174113432199431
Author(s):  
María Fabiana Jorge
Keyword(s):  
Supply Chain ◽  
Trade Policy ◽  
Pharmaceutical Products ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Us Trade Policy ◽  
Drug Supply Chain ◽  
Security Concern ◽  
The U.S

With the outbreak of the Coronavirus there is a new realization of the vulnerabilities of the U.S. drug supply chain. However, while such concerns may have been amplified by the pandemic, they preceded Covid-19 and were well documented before 2020. Indeed, in past years the U.S. Congress held several hearings addressing potential vulnerabilities in the U.S. drug supply chain, in part due to the increasing dependency on China as a dominant supplier of active pharmaceutical ingredients (APIs) and some finished pharmaceutical products. These vulnerabilities go well beyond health policy and constitute a national security concern. The article addresses how U.S. trade policy plays a significant role in shaping the pharmaceutical industry at home and abroad and is in part responsible for some of the current vulnerabilities of the U.S. drug supply chain.

scholarly journals Encapsulation of Active Pharmaceutical Ingredients in Lipid Micro/Nanoparticles for Oral Administration by Spray-Cooling

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1186
Author(s):  
Carmen S. Favaro-Trindade ◽  
Fernando E. de Matos Junior ◽  
Paula K. Okuro ◽  
João Dias-Ferreira ◽  
Amanda Cano ◽  
...  
Keyword(s):  
Oral Administration ◽  
Raw Materials ◽  
Low Cost ◽  
Pharmaceutical Formulations ◽  
Spray Cooling ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Taste And Odor ◽  
Cooling Technology ◽  
Simple Technology

Nanoencapsulation via spray cooling (also known as spray chilling and spray congealing) has been used with the aim to improve the functionality, solubility, and protection of drugs; as well as to reduce hygroscopicity; to modify taste and odor to enable oral administration; and many times to achieve a controlled release profile. It is a relatively simple technology, it does not require the use of low-cost solvents (mostly associated to toxicological risk), and it can be applied for lipid raw materials as excipients of oral pharmaceutical formulations. The objective of this work was to revise and discuss the advances of spray cooling technology, with a greater emphasis on the development of lipid micro/nanoparticles to the load of active pharmaceutical ingredients for oral administration.

scholarly journals Pharmaceutical Product Selection: Application of AHP

2017 ◽  
Vol 12 (8) ◽  
pp. 193 ◽  
Author(s):  
Farzana Elahi ◽  
Afia Muqtadir ◽  
Shahriyar Anam ◽  
K. Mustafiz
Keyword(s):  
Threshold Value ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Future Research ◽  
Care Needs ◽  
Expert Choice ◽  
Competitive Price ◽  
Quality Of Products ◽  
Hierarchy Process

Pharmaceutical industry caters to the health care needs through manufacturing drugs that cure diseases. With retailers being one of the customers in this industry, it is imperative for any pharmaceutical companyto address the issues concerning their preferences for these drugs to remain competitive in business. This prompts us to investigate the factors that influence their decisions in selecting the pharmaceutical products. This paper aims to identify those factors and rank them through application of analytical hierarchy process (AHP) with the support of the Expert Choice Software version 11.0. In this regard, six factors are identified, namely, quality of products, availability of products, variety of products, delivery deadline, flexibility in quantity, and competitive price that affect the purchasing decision of the retailers. The result indicates that among the chosen six factors, quality of products is ranked first followed by variety of products, availability of products, flexibility in quantity, competitive price, and delivery deadline. Inconsistency level as generated by the synthesis of AHP is found to be 9% that falls below the threshold value of 10%, signifying to the acceptability of the result. The implications of the findings on the part of the pharmaceutical companies and suggestions for future research are also put forward.

scholarly journals Spectroscopic Analysis of Melatonin in the Terahertz Frequency Range

Sensors ◽  
2018 ◽  
Vol 18 (12) ◽  
pp. 4098 ◽  
Author(s):  
Uroš Puc ◽  
Andreja Abina ◽  
Anton Jeglič ◽  
Aleksander Zidanšek ◽  
Irmantas Kašalynas ◽  
...  
Keyword(s):  
Spectroscopic Analysis ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Thz Spectroscopy ◽  
Terahertz Frequency ◽  
Thz Imaging ◽  
Pharmaceutical Ingredients ◽  
Indispensable Tool ◽  
First Time

There is a need for fast and reliable quality and authenticity control tools of pharmaceutical ingredients. Among others, hormone containing drugs and foods are subject to scrutiny. In this study, terahertz (THz) spectroscopy and THz imaging are applied for the first time to analyze melatonin and its pharmaceutical product Circadin. Melatonin is a hormone found naturally in the human body, which is responsible for the regulation of sleep-wake cycles. In the THz frequency region between 1.5 THz and 4.5 THz, characteristic melatonin spectral features at 3.21 THz, and a weaker one at 4.20 THz, are observed allowing for a quantitative analysis within the final products. Spectroscopic THz imaging of different concentrations of Circadin and melatonin as an active pharmaceutical ingredient in prepared pellets is also performed, which permits spatial recognition of these different substances. These results indicate that THz spectroscopy and imaging can be an indispensable tool, complementing Raman and Fourier transform infrared spectroscopies, in order to provide quality control of dietary supplements and other pharmaceutical products.

scholarly journals Risk of error estimated from Palestine pharmacists’ knowledge and certainty on the adverse effects and contraindications of active pharmaceutical ingredients and excipients

2016 ◽  
Vol 13 ◽  
pp. 1 ◽  
Author(s):  
Ramzi Shawahna ◽  
Mohammed Al-Rjoub ◽  
Mohammed M Al-Horoub ◽  
Wasif Al-Hroub ◽  
Bisan Al-Rjoub ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Multiple Choice ◽  
Community Pharmacists ◽  
Pharmaceutical Products ◽  
Active Pharmaceutical Ingredients ◽  
Multiple Choice Questions ◽  
Active Ingredients ◽  
Cross Sectional ◽  
Safety Issues ◽  
Pharmaceutical Ingredients

Purpose: This study aimed to investigate community pharmacists’ knowledge and certainty of adverse effects and contraindications of pharmaceutical products to estimate the risk of error. Factors influencing their knowledge and certainty were also investigated. Methods: The knowledge of community pharmacists was assessed in a cross-sectional design using a multiple-choice questions test on the adverse effects and contraindications of active pharmaceutical ingredients and excipients from May 2014 to March 2015. Self-rated certainty scores were also recorded for each question. Knowledge and certainty scores were combined to estimate the risk of error. Results: Out of 315 subjects, 129 community pharmacists (41.0%) completed the 30 multiple-choice questions test on active ingredients and excipients. Knowledge on active ingredients was associated with the year of graduation and obtaining a licence to practice pharmacy. Knowledge on excipients was associated with the degree obtained. There was higher risk of error in items on excipients than those on ingredients (P< 0.01). Conclusion: The knowledge of community pharmacists in Palestine was insufficient with high risk of errors. Knowledge of community pharmacists on the safety issues of active ingredients and excipients need to be improved.

scholarly journals Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e027780 ◽  
Author(s):  
Dzintars Gotham ◽  
Melissa Joy Barber ◽  
Andrew M Hill
Keyword(s):  
South Africa ◽  
Universal Access ◽  
Pharmaceutical Product ◽  
Essential Medicines ◽  
Active Pharmaceutical Ingredients ◽  
Profit Margins ◽  
Pharmaceutical Ingredients ◽  
Oral Formulations ◽  
Current Price ◽  
The Cost

ObjectivesChallenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India.DesignData on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (www.infodriveindia.com). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin.ResultsFor injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines—irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna—as well as valproic acid and ciclosporin.ConclusionsEstimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.

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.

scholarly journals PHARMACIST BEHAVIOR OF HALAL LABELIZATION ON PHARMACEUTICAL PRODUCT

2019 ◽  
Vol 2 (1) ◽  
pp. 25
Author(s):  
Ach. Syahrir ◽  
Abdul Rahem ◽  
Adistiar Prayoga
Keyword(s):  
Raw Materials ◽  
Public Awareness ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Survey Method ◽  
The Government ◽  
Strongly Agree ◽  
High Level ◽  
Development Center ◽  
The City

The survey of the research and development center of Ministry of Religion (Kemenag) of Indonesia in 2013 concluded that public awareness to consume halal products was at a high level. Although the government guaranteed halal products for the customer, the implementation is still not fully implemented. “Halal” status of the pharmaceutical product in Indonesia is still in doubt. The indicator is that 90 percent of the pharmaceutical industry's raw materials are imported materials, that have no guaranteed halal system for these products. In particular, pharmacists have an important role in the preparation of halal pharmaceutical products. Therefore, a study conducted to analyze the pharmacists' behavior regarding halal labeling of pharmaceutical products. This study focused on the behavior of pharmacists in Malang City who are members of the Indonesian Pharmacist Association/Ikatan Apoteker Indonesia (IAI) with the survey method. The objective of this study was to obtain an overview of the perception of the pharmacist on halal labeling in pharmaceutical products in Malang City. The research instrument was a questionnaire. Descriptive statistics ware used to analyze data. The results showed that pharmacists in the city of Malang accepted and strongly agree on halal labeling of pharmaceutical products.

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