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1.
Int J Pharm ; 594: 120126, 2021 Feb 01.
Article in English | MEDLINE | ID: mdl-33321167

ABSTRACT

Highly homogeneous low-dose (50 µg) tablets were produced incorporating perfectly free-flowing granules prepared by a fully integrated Continuous Manufacturing (CM) line. The adopted CM equipment consisted of a Twin-Screw Wet Granulator (TSWG), a Continuous Fluid Bed Dryer (CFBD) and a Continuous Sieving (CS) unit. Throughout the experiments a pre-blend of lactose-monohydrate and corn starch was gravimetrically dosed with 1 kg/h into the TSWG, where they were successfully granulated with the drug containing water-based PVPK30 solution. The wet mass was subsequently dried in the CFBD on a vibratory conveyor belt and finally sieved in the milling unit. Granule production efficiency was maximized by determining the minimal Liquid-to-Solid (L/S) ratio (0.11). Design of Experiments (DoE) were carried out in order to evaluate the influence of the drying process parameters of the CFBD on the Loss-on-Drying (LOD) results. The manufactured granules were compressed into tablets by an industrial tablet rotary press with excellent API homogeneity (RSD < 3%). Significant scale-up was realized with the CM line by increasing the throughput rate to 10 kg/h. The manufactured granules yielded very similar results to the previous small-scale granulation runs. API homogeneity was demonstrated (RSD < 2%) with Blend Uniformity Analysis (BUA). The efficiency of TSWG granulation was compared to High-Shear Granulation (HSG) with the same L/S ratio. The final results have demonstrated that both the liquid distribution and more importantly API homogeneity was better in case of the TSWG granulation (RSD 1.3% vs. 4.5%).


Subject(s)
Excipients , Technology, Pharmaceutical , Drug Compounding , Particle Size , Powders , Tablets , Temperature
2.
C R Acad Hebd Seances Acad Sci D ; 280(19): 2253-6, 1975 May 21.
Article in French | MEDLINE | ID: mdl-807412

ABSTRACT

RNA and protein synthesis in Planarian cells cultivated in vitro was studied by histoautoradiography. In the non-differentiated cells, uptake of precursor is intense from the beginning of the culture, and sensitive to addition of trophic factor known for their activating effect on mitosis and regeneration. On the contrary the rate of incorporation in differentiated cells is low and uniform, independently of the differents factors added to the medium.


Subject(s)
Cell Differentiation , Planarians/metabolism , Protein Biosynthesis , RNA/biosynthesis , Turbellaria/metabolism , Autoradiography , Cell Differentiation/drug effects , Cell Division/drug effects , Cells, Cultured , Head , Leucine/metabolism , Planarians/cytology , Planarians/physiology , Regeneration/drug effects , Uridine/metabolism
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