Particle Engineering of an Active Pharmaceutical Ingredient for Improved Micromeritic Properties

2017 ◽  
Vol 40 (7) ◽  
pp. 1282-1292 ◽  
Author(s):  
Michał Sowa ◽  
Anneke R. Klapwijk ◽  
Michael Ostendorf ◽  
Wolfgang Beckmann
Author(s):  
Jan M Keppel Hesselink

Topical analgesics are regarded as new inroads to treat peripheral neuropathic pain, with a number of advantages over oral treatments. Topical treatment reduces systemic induced side-effects and have good tolerability, without problems of misuse or abuse, or dependency. Furthermore, the onset of action is fast, mostly within 30 minutes. The mechanism of action of topical analgesics is either via transdermal delivery of the analgesic, or via intradermal mechanisms of action. In the latter case, plasma levels of analgesics in the blood are absent or very low. This perspective is missing in the approach of the ad hoc committee of the National Academies of Sciences, Engineering, and Medicine in the USA, installed by the FDA. In this short commentary, we plead for a more comprehensive approach of topical analgesics, including those formulations which explicitly are not based on transdermal penetration of the active pharmaceutical ingredient, but on intradermal mechanisms of action.


Author(s):  
N B Bhagat ◽  
A V Yadav ◽  
P R Mastud ◽  
R A Khutale

In this article we describe the optimizing parameters in the process of spherical crystallisation. Particle engineering of active pharmaceutical agents is an innovative area of research in pharmaceutical industry because of several advantages. Spherical crystallization is one of the particle engineering technique in which drug directly gets crystallized and agglomerated into spherical shape. The spherical crystals can be obtained by different methods like solvent change, Quasi-emulsion droplet, ammonia diffusion and neutralisation. The optimization of process of spherical crystallization is important for obtaining the ideal spherical crystal agglomerates. It includes stirring rate, selection of solvent, pH, temperature etc. which affects on the physico-chemical properties of crystals. These optimizing parameters play its specific role in formation of spherical crystals. Stirring rate affects the shape as well as size of the final agglomerates and solvent selection helps in the formation of maximum amount of agglomerates in the system. The factors like pH and temperature should be maintained in case of drugs which show polymorphism. Apart from this, several others physical phenomenon or parameters like interfacial tension and rate of crystallisation are also important for thorough optimization of process.  


Author(s):  
L.E. Yasinskaya ◽  

Introduction. Earlier, the comparative analysis of the commercial and investment activities of the companies that play the key roles in the investment processes in the Russian pharmaceutical industry and operate within the four main business models (biotechnological, generic, specialized pharmaceutical companies, active pharmaceutical ingredient (API) manufacturers) has been conducted. No full assessment of the companies’ activitiesis conceivable without a financial analysis of their activities to identify the risks of investment activities. Objective of the study. A detailed comparative analysis of the financial standing of domestic pharmaceutical manufacturers operating within the selected business models for further identification of potential financial risks for investors. Research procedure and article structure. Analysis of RAS statements (forms 1 and 2) of 72 over 500 million revenue companies grouped together as selected business models for the period from 2015 to 2019. Results. The researchers provided a detailed description of the commercial activities of domestic pharmaceutical companies within the business models under consideration. The companies within various business models showed positive revenue growth rates over the past five years. All business models demonstrate consistently high business profitability and a significant share of own capital in the asset profile. Conclusion. The results of the study show the stable financial standing of the pharmaceutical companies within various business models. The biotechnology sector companies that are the most attractive for investments have the highest quality financial standing. The specialized and generic companies show similar consistently strong performance. API manufacturers that the companies with relatively small revenues are actively developing and are attractive to restrained budget investors.


2015 ◽  
Vol 21 (40) ◽  
pp. 5789-5801 ◽  
Author(s):  
Sachin Thakkar ◽  
Kristin Fathe ◽  
Hugh Smyth
Keyword(s):  

2020 ◽  
Vol 15 ◽  
Author(s):  
Samar R. Saleh ◽  
Mariam M. Abady ◽  
Mohammed Nofal ◽  
Nashwa W. Yassa ◽  
Mohamed S. Abdel-latif ◽  
...  

Background: Berberine (BBR), an isoquinoline alkaloid, acts as a multipotent active pharmaceutical ingredient to counteract several types of dementia based on its numerous pharmacological actions including antioxidant, antiinflammatory, cholesterol-lowering effect, and inhibition of Aβ production and AChE. However, BBR suffers from poor absorption, bioavailability and brain drug uptake. The present study is directed for the formulation and characterization of Chitosan BBR-nanoparticles (BBR-NPs) as well as the estimation of its neuroprotective effects against scopolamine induced cognitive impairments. Methods: BBR-NPs were formulated using ionic gelation method and tripolyphosphate was chosen as a cross linker. Nanoparticles size, zeta potential, encapsulation efficiency and releasing profile were estimated. To investigate the neuroprotective effects, adult fifty six Wistar male rats were randomly distributed into: three control groups, received saline, polyethylene glycol or chitosan- NPs respectively; induced group, received scopolamine (2 mg/ kg, i.p.) and three treated groups were orally administrated BBR (50 mg/ kg), BBR- NP (7 mg/ kg) and donepezil (2.25 mg/ kg, as positive control) followed by scopolamine injection after 40 min, daily for 4 weeks. Morris water maze test, oxidative stress parameters, cholinergic and amyloid-β processing intermediates as well as neuroplasticity markers and histopathological examination were assessed. Results: Our results showed that BBR- NPs were better than BBR and donepezil as BBR- NPs were powerful inhibitory ligands toward AChE and Aβ42 formation and significantly down regulated Tau, iNOS and BACE gene expression in rats’ hippocampus. BBR-NPs administration, at 1/6 of BBR therapeutic recommended dose, significantly improved learning and memory function. This could be accredited to the diminution of oxidative stress and amyloid-β toxicity in addition to the improvement of the neuroplasticity markers. Conclusions: The enhancing effect of BBR- NPs could be related to the enhancing of its bioavailability, absorption and brain drug uptake which need more investigation in future work.


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