Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 187 (2023))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 1,2*Part 1,1 see Pharm. Ind. 2022;84(12):1440–1450 · Pöllinger N · Glatt Pharmaceutical Services GmbH & Co. KG, Binzen
Many pharmaceutical drug compounds are poorly water-soluble or almost insoluble in water. Drug solubility is one of the most important parameters to achieve therapeutic concentration. Nowadays around 70 % of newly discovered drug candidates and approximately 40 % of marketed oral drugs are categorized as practically insoluble [ 44 ]. Suitable technical operations in order to ensure adequate solubility and bioavailability can provide multiparticulates with their particular advantages. Microenvironmental pH modulation is required for many basic drugs, with the aid of weak acids such as tartaric acid ( fig. 12 ). Due to the high hygroscopicity of weak acids, the probability of degradation ...

Multiparticulates

Rubrik: Originale

(Treffer aus pharmind, Nr. 12, Seite 1440 (2022))

Pöllinger N

Multiparticulates / Modern Oral Drug Products for our Society – Part 1,1 · Pöllinger N · Glatt Pharmaceutical Services GmbH & Co. KG, Binzen
Drug Layered Pellets Matrix Pellets (Amorphous) Solid Dispersions SEDDS Optimized Solubility Bioavailability Orally administered dosage forms are and will continue to be a standard of practice in medication across patient groups, including children and the elderly patient population. For synthetically manufactured drug substances, oral administration is the worldwide most frequent and popular drug administration route used in medical practice today. The popularity of the oral route is a result of several inherent advantages which impact all key stakeholders in the pharmaceutical paradigm, including patients, healthcare providers, manufacturers, and regulators. A few advantages of oral drug products over alternative delivery routes ...

Technical Due Diligence in the Pharmaceutical Industry

Rubrik: Praxis

(Treffer aus pharmind, Nr. 10, Seite 1523 (2016))

Ettner A | Pöllinger N

Technical Due Diligence in the Pharmaceutical Industry / Detecting the (early) warning signs or optimizing when it’s too late · Ettner A, Pöllinger N · Glatt GmbH, Binzen
The term “due diligence”(DD) originated in the US in the Securities Act of 1933,which regulates the liability of those involved in offering and selling securities and refers to the “due diligence” required when checking for existing risks. In the pharmaceutical industry, evaluations or risk evaluations are performed, e.g., when companies or business units are acquired or when licensing dossiers or marketing authorizations (MA) are obtained. In addition to the technical evaluation, there are also legal, financial and tax evaluations. Technical Due Diligence means the duly diligent risk evaluation of a technology. In this context, the term “technology” includes specific knowledge, ...