Entries by Bastian Arlt
Water-insoluble weakly basic actives on tartaric acid beads – a DoE case study
Abstract Yes, the headline is long, the overall topic not easy, and the combination of water-insoluble weakly basic actives with a DoE (Design of Experiments) method based on functional starter beads requests more than basic knowledge. With the help of a CDMO – such as Glatt Pharmaceutical Services, Binzen/Germany – the topic is immediately simplified. […]
Analytics of Dipyridamole Modified Release Capsules
Abstract on dipyridamole formulations A robust headspace gas chromatographic method was developed for the quantitative determination of two chemicals – acetone and isopropyl alcohol – which occur in dipyridamole modified release capsules. Due to the weakly basic properties of dipyridamole, tartaric acid pellets (TAP) are used as starter cores for this formulations. The API layered […]
Dabigatran Formulation for Oral Administration – an Evaluation
Abstract Dabigatran etexilate mesylate is a pro-drug of Dabigatran – a BSC Class II drug used as anti-coagulant in deep vein thrombosis as a direct thrombin inhibitor. Due to increasing solubility in the acidic regime, tartaric acid pellets (TAP) are used as starter beads. A processed formulation is compared with the existing formulation from the […]
BSC Class IV APIs in oral formulations
APIs of BSC Class IV in oral formulations represent one of four groups following the Biopharmaceutical Classification System (BCS). The BCS predicts potential effects of oral formulations on the human drug oral bioavailability. Thereby, it is a scientific tool differentiating the drug substances on the basis of solubility and intestinal permeability under prescribed condition. While […]
Influence of tartaric acid pellets on the release behavior of a basic drug
Abstract The objective of this study is to investigate the influence of tartaric acid pellets on the release behavior of a basic drug. By applying an acid micro-environment, the release profiles of Papaverine HCI was dramatically improved. Formulations with weakly basic drugs Papaverine HCl is an opium alkaloid antispasmodic drug, used in the treatment of […]
Tartaric acid starter pellets as pH-modifier for basic drugs
Introduction We will introduce tartaric acid starter pellets as pH-modifier for basic drugs. Tartaric acid is widely used in food products, oral, topical and parenteral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. In general, tartaric acid is also used in beverages, confectionary, food products and pharmaceutical formulations as an acidulant, […]
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