Pharmaceutical industry before COVID-19

The 2019 CPhI Annual Report describing rankings, innovations and key trends in pharma industry is summarized. Pharmaceutical markets were assessed based on the following indicators: growth potential, API manufacturing, innovation, competitiveness and finished product. The top three markets are USA, Germany and Japan, while China has made the largest overall improvement. Interestingly, UK demonstrated the largest growth decrease among all the markets reported. The fact is attributed to Brexit. The winner of CPhI Award was PolarDry® Electrostatic Spray Dryer. Thanks electrostatic induction applied in spraying nozzle, polar solvent is moved to the surface and non-polar ingredients into center of droplets. The most promising recent drug delivery devices were drug patches, smart dose injectors, multidose delivery injectable caps and smart dry powder inhalers. The most anticipated drug delivery devices are needle-free devices, wearable delivery devices, pre-filled syringes and dual chamber products as well as autoinjectors and pens. A few preselected articles were briefly summarized. Bikash Chatterjee from Pharmatech Associates described evolution of industry called Pharma 4.0. The key assumptions are gathering of data from across the global supply chain by smart sensors and devices referred to Internet of Things, the data evaluation by applying Artificial Intelligence tools and finally complete integration of databases. Mr. Girish Malhotra presented trends in global quality assurance. The following worth to be highlighted: necessity of technological improvements in manufacturing oriented on costs optimization and the highest possible drug products quality, standardization of requirements for drug products quality assessment. The regulatory agencies are oriented to enforce changes implementation by hesitant companies. D.M. Ecker and P. Seymur from BioProcess Technology Group presented "Mammalian Biomanufacutring Industry Overview". Vicky Qing Xia described rapidly growing biotechnological market of China. M.E.Ultee paid attention on developing gene therapies market in US

Optimization of furosemide liquisolid tablets preparation process leading to their mass and size reduction

The great number of drug substances currently used in solid oral dosage forms is characterized by poor water solubility. Therefore, various methods of dissolution rate enhancement are an important topic of research interest in modern drug technology. The purpose of this study was to enhance the furosemide dissolution rate from liquisolid tablets while maintaining an acceptable size and mass. Two types of dibasic calcium phosphate (FujicalinÆ/EmcompressÆ) and microcrystalline cellulose (VivapurÆ 102/VivapurÆ 12) were used as carriers and magnesium aluminometasilicate (NeusilinÆ US2) was used as a coating material. The flowable liquid retention potential for those excipients was tested by measuring the angle of slide. To evaluate the impact of used excipients on tablet properties fourteen tablet formulations were prepared. It was found that LS2 tablets containing spherically granulated dibasic calcium phosphate and magnesium aluminometasilicate exhibit the best dissolution profile and mechanical properties while tablets composed only with NeusilinÆ US2 was characterized by the smallest size and mass with preserved good mechanical properties and furosemide dissolution

Molecular dynamics and physical stability of ibuprofen in binary mixtures with an acetylated derivative of maltose

In this paper, we explore the strategy increasingly used toimprove the bioavailability of poorly water-soluble crystalline drugs byformulating their amorphous solid dispersions. We focus on the potentialapplication of a low molecular weight excipient octaacetyl-maltose (acMAL) toprepare physically stable amorphous solid dispersions with ibuprofen (IBU)aimed at enhancing water solubility of the drug compared to that of itscrystalline counterpart. We thoroughly investigate global and local moleculardynamics, thermal properties, and physical stability of the IBU+acMAL binarysystems by using broadband dielectric spectroscopy and differential scanningcalorimetry as well as test their water solubility and dissolution rate. Theobtained results are extensively discussed by analyzing several factorsconsidered to affect the physical stability of amorphous systems, includingthose related to the global mobility, such as plasticization/antiplasticization effects, the activation energy, fragility parameter, and thenumber of dynamically correlated molecules as well as specific intermolecular interactions like hydrogen bonds, supporting the latterby density functional theory calculations. The observations made for the IBU+acMAL binary systems and drawn recommendationsgive a better insight into our understanding of molecular mechanisms governing the physical stability of amorphous solid dispersions

Analysis of wet granulation process with Plackett-Burman design : case study

According to Process Analytical Technology perspective, drug product quality should be ensured by manufacturing process design. Initial step of the process analysis is investigation of critical process parameters (CPPs). It is generally accepted to type the CPPs based on project team knowledge and experience [5]. This paper describes the use of Design of Experiments tool for selection of the CPPs. Seven factors of wet granulation process were investigated for criticality. Low and high levels of each factor represented maximal and minimal settings of wide operational ranges. Granulates were produced in line with Plackett-Burman experimental matrix, blended with extra-granular excipients and compressed into tablets. Semi-products and final products were tested. Out of specification result of any critical quality attribute was treated as critical failure. The highshear granulation factors, i.e. quantity of binding solution, rotational speed of impeller and wet massing time were considered of critical importance. Operational ranges of the parameters were optimized. The process performance was confirmed in qualification trials