02. October 2018
The production of 3D-printed drugs holds promise for future personalized medicine. Here, we prepared tablets containing naftopidil as a model drug using a semi-solid extrusion-type 3D bioprinter applicable for tissue engineering. A hydrogel is typically used as the printer ink for 3D bioprinters, and we incorporated various amounts of hydroxypropyl methylcellulose hydrogel (30%, 40% and 50% gel) into the printer ink. The resulting 3D-printed gel product was dried to obtain tablets. The...
12. March 2017
Abstract Novel excipients are entering the market to enhance the bioavailability of drug particles by having a high porosity and thus providing a rapid liquid uptake and disintegration to accelerate subsequent drug dissolution. One example of such a novel excipient is functionalised calcium carbonate (FCC), which enables the manufacture of compacts with a bimodal pore size distribution consisting of larger inter-particle and fine intra-particle pores. Five sets of FCC tablets with a target...
22. February 2017
Abstract Caffeine increases the analgesic properties of acetaminophen and therefore it is reasonable to use both substances together in one drug form in stronger pain. Currently, there are no commercially available pharmaceutical combination products containing acetaminophen and caffeine, which is present as granules. The aim of the study was to obtain twelve different granules with these therapeutic substances and determine the effect of various excipients on the quality of the drug form. All...
15. February 2017
Diclofenac potassium is an anti-inflammatory agent classified as a class II drug as per the biopharmaceutical classification system (BCS). The poor dissolution rate of water-insoluble drugs is still a major problem confronting the pharmaceutical industry. There are several techniques to enhance the dissolution of poorly soluble drugs. Methods available include salt formation, micronization and addition of solvent or surface active agents. The objective of the present work is to improve the...
13. February 2017
Abstract Poloxamer 188, a commonly used emulsifying and solubilizing agent, was found to be the cause of crystallization of an investigational drug, AMG 579, from its amorphous solid dispersion at accelerated storage conditions. Investigation of this physical stability issue included thorough characterization of poloxamer 188 at non-ambient conditions. At 40 °C, poloxamer 188 becomes deliquescent above relative humidity of 75%. Upon returning to ambient conditions, the deliquescent poloxamer...
06. January 2017
Abstract Microcrystalline cellulose (MCC) HiCelTM is native from cellulose, which is manufactured from wood pulp. Microcrystalline cellulose is made by hydrolysis reaction at temperature and pressure in presence of catalyst, which acts as reaction process increment. It is neutralized after completion of hydrolysis and intended to be used as to make microcrystalline cellulose powder. HiCelTM MCC is white crystalline, free flowing powder and medium in particles size. MCC is free flowing with...
17. November 2016
Abstract Amorphous state of drugs increases the oral bioavailability, but typically faces physical stability problems. Amorphous rutin was generated and physically stabilized by encapsulating inside mesopores of porous AEROPERL® 300 Pharma and named as rutin CapsMorph® in this study. AEROPERL® 300 Pharma was loaded with rutin dissolved in DMSO containing Tween 80, and subsequently the solvent evaporated (wetness impregnation method). The loading process was monitored by light microscopy and...
08. August 2016
Abstract Control and optimization of the physical properties of a drug substance (DS) are critical to the development of robust drug product manufacturing processes and performance. A lack of isolatable, for example, crystalline, DS solid forms can present challenges to achieving this control. In this study, an isolation scheme for an amorphous DS was developed and integrated into the synthetic route producing DS with optimized properties. An inert absorbent excipient (Neusilin® US2) was used...
17. July 2016
Abstract Objectives: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies. Methods: We investigated...
07. December 2015
It is rare to have a pharmaceutical dosage form presented with just the pure active pharmaceutical ingredient because the drug substance does not possess adequately desirable physical attributes to be processed into the final dosage form. Consequently, additives or excipients which are inert ingredients serving a functional purpose are added to enhance the overall properties of the final formulation for ease of processability or drug product performance. More