Product Description

Carrageenans are a naturally occurring family of polysaccharides derived from red seaweed. FMC BioPolymer has advanced manufacturing capabilities to provide high quality and consistent Gelcarin,Viscarin and SeaSpen PF carrageenan products that provide a wide range of rheology properties in gelling and viscosifying pharmaceutical applications. The availability of a reliable pharmaceutical source of these highly functional excipients presents new formulation and product possibilities.

Three basic types of carrageenan make up the range of products and properties available. These types are kappa, iota and lambda carrageenan. Originating from the same polysaccharide backbone, these polymers differ primarily in the number and location of sulfate ester substitution. This gives each type of carrageenan a specific set of properties, which are outlined below:

Applications

Current marketed products containing carrageenan include cough/cold liquids, antibiotic suspensions, topical lotions and creams, and medicated shampoos. New applications for carrageenan continue to be developed and commercialized due to its unique high performance rheology features. Examples of emerging functionality and applications include: bio adhesion in oral liquid products, shape retention in vaulted cavity delivery systems such as otic and vaginal, suppository formulation, and controlled release delivery. We can provide further information on unique drug delivery employing the features of cargeenan. A variety of technical literature is available upon request. You may also contact your nearest representative.

The functional properties defined by sulfate substitution suggest a variety of potential applications. The functions of interest include:

• Gel formation - Kappa and iota types will set up gel structures that are thermally reversible. The former creates a stiff, strong gel structure, useful in applications that require shape retention such as otic and vaginal, suppository formulation, and controlled release delivery. Iota gels are flexible, elastic gels which, when broken, will reheal into a gel structure, useful in film formation or spreading applications.
• Particulate suspension - A three-dimensional network established with certain carrageenans provides excellent suspension functionality. They also can yield a thixotropic character, yielding a pourable liquid that reforms a gel for long term stability of a pharmaceutical suspension.
• Control of flow properties - Lambda carrageenans offer high performance viscosifier functionality. The ultimate viscosity in a formulation can be carefully controlled by the use of metal ions. Because of defined, reversible thermal gelling/melting properties, kappa and iota carrageenans offer a thermal control mechanism that can prove valuable in processing and manufacturing a product and in delivering the drug.
• Water binding - All carrageenans have excellent water binding capabilities. This is particularly useful in topical dosage forms, and leads to a pleasant skin feel without the sticky feeling imparted by synthetic gelling agents.

Grades of USP/NF Carrageenan
FMC BioPolymer offers six carrageenan products. Gelcarin GP-911 and GP-812 are primarily kappa type carrageenans, forming hard, brittle gels. Gelcarin GP-379 is an iota based product, yielding an elastic gel. Two lambda based products, Viscarin GP-109 and GP-209, offer a range of viscosifying properties.

SeaSpen PF is specially formulated to offer ease of use in processing and effective hydration in dry, reconstitutible suspension formulations. It possesses delayed gelling properties so that added ingredients can be thoroughly mixed and distributed in the system before a gel structure is established. Upon mixing and set up of the gel, a stable suspension of drug is obtained.

Dispersion and Hydration Procedures
As with hydrocolloids in general, proper dispersion and hydration of carrageenan is important to realizing the full benefits of its performance.

Generally, carrageenan should be dispersed in cold water, and then heated above its solubility temperature to obtain optimum functionality. The solubility temperature will depend on the level of potassium and calcium ions associated with the carrageenan or the amount of salt present in the water. Both kappa and iota carrageenans typically require heating to 170-175°F for complete solubility.

For easy dispersion and to avoid lumping, use any of the following recommendations:

• Premix the carrageenan with a dispersant, such as sugar. Use a minimum of 3 parts by weight of the sugar before dispersing in cold water. The carrageenan can also be blended with the dry ingredients in the formulation to avoid lumping, OR
• Disperse carrageenan in liquid sugar, salt, or glycerine if present in the formulation. These ingredients retard the hydration of carrageenan which make it easier to disperse and dissolve.
• THEN add the carrageenan product slowly at the vortex of rapidly agitating fluid.
• MAINTAIN vigorous agitation with a high speed mixer.
• THEN heat carrageenan to 180°F to solubilize, unless the carrageenan is designated to be cold soluble or swelling. Cold soluble carrageenans may be dispersed into cold water by adding the carrageenan powder slowly with agitation. Premixing with sugar is recommended.

Detailed Product Description

Carrageenan meets the standards set forth in the current United States Pharmacopeia/National Formulary. FMC BioPolymer maintains a Drug Master File at the U.S. Food and Drug Administration to support the use of carrageenan in drug products. Carrageenan "chondrus extract" is generally recognized as safe by qualified experts and is in accordance with United States Food and Drug Regulations (21 CFR 182.7255).Additional regulatory information is available upon request.

Re-evaluation Date/Stability of Carrageenan

Production Site

Carrageenan is manufactured out of FMC BioPolymer's Rockland, Maine facility.

Kosher Status

Carrageenan is certified as Kosher. For certificates, please contact FMC BioPolymer

Product Brochure

For a copy of a product brochure, please click here.

MSDS

For a copy of the MSDS, please click here