Bioavailability Enhancement of Poorly Soluble APIs - A WIDE SOLUBILIZERS OFFERING

CLARIANT SOLUBILIZERS

Poor bioavailability of API continues to be the biggest challenge to the formulators. Factors affecting the bioavailability of API are related to its solubility, permeability, stability, pharmacokinetic/pharma codynamic profile (PK/PD), targeted vs. non-targeted drug delivery and formulation. Not all these factors can be equally well influenced. Usually, the main approach in pharmaceutical R&D is to increase the solubility of the API, enhance API stability and optimize the formulation.

Improvement of the PK/PD profile may be achieved e.g. via modification of the release profile of a dosage form. To improve the absorption of the API by the body, formulators usually focus on enhancing the solubility and not the permeability of the API as the former can be more easily achieved and represents a major limitation for API bioavailability. By enhancing their bioavailability, more APIs and formulations may reach the market, the R&D costs are reduced, and the time-to-market period is shortened.

Solubilizers are still common and first choice adopted by formulators to tackle API solubility issue due to their easy handling and well established safety profile. Clariant offers a wide range of choices of solubilizers which are produced under IPEC GMP standard and naturally compliant to pharmacopoeias. These solubilizers are mainly classified into the category of solvents, PEG-derivatives and Poloxamers.

Types	Name	Pharmacopeial Name	Monograph
Solvents	VitiPure LEX 300/400	Polyethylene Glycol 300/ 400 Macrogol 300/ 400	USP/NF Ph.Eur. JP
PEG-Derivatives	VitiPure HCO 40	Polyoxyl 40 Hydrogenated Castor Oil Macrogolglycerol Hydroxystearate	USP/NF Ph.Eur.
	VitiPure CO 35	Polyoxyl 35 Castor Oil Macrogolglycerol Ricinoleate	USP/NF Ph.Eur.
	VitiPure L 20	Polysorbate 20	USP/NF Ph.Eur.
	VitiPure O 80	Polysorbate 80	USP/NF Ph.Eur.
Poloxamers	VitiPure P 188	Poloxamer 188	USP/NF Ph.Eur.

With our pharmaceutical GMP facilities in Germany, Spain and China Clariant thrives to provide high quality and innovative excipients into various pharmaceutical applications. Clariant is largest supplier of Polyethylene glycols and trusted supplier for pharmaceutical raw material with proven track record.

VITIPURE™ LEX 300 & 400

Polyethylene glycol with stringent control of microbial load for pharmaceutical Industry.

Clariant is a global supplier of pharmaceutical grade polyethylene glycols (PEG). With decades of experience in the production and supply of high-quality PEGs Clariant has further expanded its PEG portfolio with low microbial load variant. VitiPure™ LEX 300 & 400 surpass the current pharmacopoeia requirements and support the needs of customers who require stringent control on microbial load in their formulations.

KEY INFORMATION – MICROBIAL LOAD

Endotoxin: max. 1 IU/ml
TAMC: max. 50 cfu/g
TYMC: max. 50 cuf/g
Salmonella: absent
Staphylococcus aureus: absent
Escherichia coli: absent
Pseudomonas aeruginosa: absent

BENEFITS

Low microbial load for high risk applications
Surpass the current pharmacopoeia requirements
Supports risk assessment in pharmaceutical and biopharmaceutical manufacturing

APPLICATION & FUNCTIONALITY

Safe and widely used pharmaceutical solvents for varieties of different APIs which are difficult to dissolve in water
Applied in liquid and semi-solid formulations
Excellent hygroscopicity, perfect as humectants

VITIPURE™ CO 35

Solubiliser and emulsifying agent for the human and veterinary pharmaceutical industries

KEY INFORMATION

Generic names: Polyoxyl 35 Castor Oil (USP)
- Macrogolglycerol Ricinoleate (Ph. Eur.)
Chemical nature: VitiPure CO 35 is a nonionic solubiliser and emulsifier made by reacting 1 mole of castor oil with 35 moles of ethylene oxide
CAS no.: 61791-12-6
GMP: IPEC
Retest period: 2 years
Packaging sizes: 100 kg steel drum (epoxy coated in-liner) and 25kg steel drum (epoxy coated in-liner)
Sample size: 0.5 kg

KEY BENEFITS

Increases bioavailability when used in SEDDS
Emulsifies or solubilizes the fat-soluble vitamins A, D, E and K in aqueous solutions for oral and topical administration.
Aqueous solutions of hydrophobic drugs (e.g. Miconazole, Hexedetine, Clotrimazole, Benzocaine etc.) can be prepared using VitiPure CO 35

SAFETY

World-wide several registered Pharmaceutical OTC and prescription medicines
Listed in the inactive ingredient database of the FDA

FDA PUBLISHED APPLICATIONSDosage & Applications* — FDA PUBLISHED APPLICATIONS Dosage & Applications*

See the full technical brochure on A WIDE SOLUBILIZERS OFFERING here

(click the picture to download the brochure)

Source: Clariant Health Care, technical brochure A WIDE SOLUBILIZERS OFFERING

Interested in more information about Clariant Health Care excipients?

Name *

First

Last

Email *

Company *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Comment or Message *

I agree with the privacy policy as per https://www.pharmaexcipients.com/privacy/ . The contact details will be shared with the supplier who holds the request above. The supplier can contact you directly.

Name