The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB 1 to OEB 5-6 degree…
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be considered by an institution to…
Physicochemical properties are all the physical and chemical properties of a drug, which are influence the drug performance or action. Various Physico-Chemical Properties of Drugs Thermodynamic properties Kinetic properties Spectroscopic properties Surface properties Mechanical properties Packing properties If a deficiency is detected, then the project team should decide on the molecular modification(s) that would most…
This guidance document was published by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC for cleaning validation in active pharmaceutical ingredient manufacturing plants. Six specific areas are addressed in this Guidance document: Acceptance Criteria Companies must demonstrate during cleaning validation that the cleaning procedure routinely employed…
The solubility of drug molecule is one of the most challenging aspect in formulation development. It is crucial to ensure the right concentration of a drug gets into the bloodstream so the bioavailability of the drug causes the desired pharmacological response. Therefore, using a variety of techniques to improve solubility helps drug companies launch a…
Drug discovery is part luck and part structured investigation. At the beginning of the 19th century it was largely carried out by individuals but it now requires teamwork, the members of the team being specialists in various fields, such as medicine, biochemistry, chemistry, computerized molecular modeling, pharmaceutics, pharmacology, microbiology, toxicology, physiology and pathology. The approach…
Solubility is defined as the upper limit of solute that can be dissolved in a given amount of solvent at equilibrium. It is also called the ability of substance to dissolve in a solvent.orThe solubility is defined as the concentration of the solute in solution when it is in equilibrium with the solid substance at…