What is Solutol HS 15?

What is Solutol HS 15?

Solutol HS15 (polyoxyethylene esters of 12-hydroxystearic acid) is an amphiphilic nonionic surfactant made by fusing fatty acids and end-capped methoxy polyethylene glycol (mPEG) and demonstrated biocompatibility [192]. From: Nanotechnology-Based Targeted Drug Delivery Systems for Lung Cancer, 2019.

What is a novel excipient?

ICH, EMA: A novel excipient is an excipient which is being used for the first time in a drug product, or by a new route of administration. It may be a new chemical entity or a well-established one which has not yet been used for human administration and /or for a particular human administration pathway.

What is Kolliphor HS 15?

Kolliphor® HS 15 is an exceptional solubilizer with attributes suited for parenteral and oral formulation of poorly soluble molecules. As a consequence, it is primarily used in screening of new chemical entities (NCEs) and also used as a vehicle in delivery of molecules encapsulated in micelles or micro-emulsions.

Is solutol a surfactant?

Solutol HS15 (polyoxyethylene esters of 12-hydroxystearic acid) is an amphiphilic nonionic surfactant made by fusing fatty acids and end-capped methoxy polyethylene glycol (mPEG) and demonstrated biocompatibility [192].

What is Cremophor used for?

Cremophor EL (CrEL) is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel (Taxol). In contrast to earlier reports, CrEL is not an inert vehicle, but exerts a range of biological effects, some of which have important clinical implications.

Do excipients need to be GMP manufactured?

The excipient starting materials may not be required to be manufactured in accordance with Good Manufacturing Practice (GMP) requirements for excipients (for example as in the IPEC-PQG GMP Guide1) because these other uses of the material do not demand the adoption of GMP.

What are excipients used for?

Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability.

What is polyethylene glycol 15 Hydroxystearate?

Polyethylene glycol 15 hydroxystearate (synonym: polyoxl-15-hydroxystearate) is a reaction product of 12-hydroxystearic acid with 15 moles of ethylene oxide. This non-ionic surfactant belongs to the family of polyethylene glycol fatty esters or polyethylene glycol esters of fatty acids.

What is Soluplus?

Soluplus (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (PCL-PVAc-PEG)) (Figure 1) is a new pharmaceutical excipient designed originally for preparing solid solutions of poorly water-soluble drugs by hot-melt extrusion technology [20.

Do excipients need FDA approval?

Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or …

Is DMF required for excipients?

An Excipient DMF is not required by law or FDA regulations. It is submitted solely at the discretion of the holder. It is not approved or disapproved. The DMF is maintained as a confidential document that cannot be submitted to third parties without the written agreement of the excipient ingredient manufacturer.

What are the types of excipients?

Excipients by Origin: Organic Chemicals

• Fillers & Diluents.
• Binders.
• Suspension & Viscosity Agents.
• Coatings.
• Flavoring Agents.
• Disintegrants.
• Colorants.
• Lubricants & Glidants.

What is an excipient give example?

Examples include gelatin, cellulose, cellulose derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol. Dry binders are added to the powder blend, either after a wet granulation step, or as part of a direct powder compression (DC) formula.

What is macrogol stearate?

Macrogol stearate is a chemical compound, hydroxypolyether and an octadecanoate ester. It is used in cosmetics as a surfactant and emulsifier. Also see Macrogol 4000. Molecular Formula: C20H40O3. Molecular Weight: 328.5 g/mol.

Is Soluplus a surfactant?

A hydrophilic polymer – Kollidon VA 64 (VA64) and a polymeric surfactant Soluplus were employed as matrix respectively in the optimized formulations. The dissolution profiles of extrudates were significantly higher than those of SDs prepared with solvent-evaporation method.

How does Soluplus dissolve?

Soluplus® is soluble in water. Furthermore, it is soluble in acetone (up to 50%), methanol (up to 45%), ethanol (up to 25%), dimethylformamide (up to 50%) and in mixtures of (1:1 m/m) methanol/ acetone (up to 50%) and (1:1 m/m) ethanol/acetone (up to 45%).

Is Cremophor a polyethylene glycol?

Cremophor is a non-ionic solubilizer and emulsifier that is made by reacting ethylene oxide with castor oil [1]. It is a pale yellow oily liquid consisting of a mixture of components, primarily polyethylene glycol conjugates.

Does docetaxel contain Cremophor?

Docetaxel adopts polysorbate 80 instead of cremophor. Nevertheless, hypersensitivity reactions occur with polysorbate 80-containing docetaxel as well.