Gellan Gum – Pharmaceutical Excipients

Gellan Gum is a versatile polysaccharide that has found extensive applications in various industries, including the pharmaceutical sector. Known for its unique rheological properties and gelling abilities, gellan gum has become a popular choice for pharmaceutical formulations, contributing to the stability and performance of various drugs.

Manufacturing of Gellan Gum

Gellan Gum is naturally produced by the bacterium Sphingomonas elodea. This bacterium ferments carbohydrates, such as glucose, to produce gellan gum as an extracellular polysaccharide. The fermentation process results in the formation of a high molecular weight, anionic polysaccharide with unique gelling properties.

The manufacturing process of pharmaceutical-grade gellan gum involves the following steps:

1. Fermentation: Sphingomonas elodea is cultured in a fermentation medium containing glucose or other carbohydrates. The bacterium undergoes fermentation, producing gellan gum as a byproduct.
2. Isolation: After fermentation, the gellan gum is isolated from the fermentation broth. This can be achieved through processes such as precipitation, centrifugation, and purification.
3. Drying: The isolated gellan gum is then dried to obtain the final product, which can be in the form of powder or granules.
4. Quality Control: The pharmaceutical-grade gellan gum undergoes rigorous quality control measures to ensure purity, consistency, and adherence to regulatory standards.

Function of Gellan Gum as Excipients

Gellan Gum has several applications in the pharmaceutical industry, primarily due to its unique gelling and stabilizing properties. Some key applications include:

1. Drug Delivery Systems: Gellan Gum is used in the formulation of controlled-release drug delivery systems, providing a sustained release of active pharmaceutical ingredients.
2. Suspensions and Emulsions: It is employed in the preparation of suspensions and emulsions, enhancing the stability and shelf life of pharmaceutical formulations.
3. Gel Formulations: Gellan Gum is utilized to create gels in pharmaceutical formulations, improving the texture and consistency of oral and topical products.
4. Viscosity Modifiers: The polysaccharide acts as a viscosity modifier, influencing the flow characteristics of pharmaceutical formulations.
5. Stabilizer in Liquid Formulations: It acts as a stabilizer in liquid formulations, preventing phase separation and maintaining the homogeneity of the product.
6. Binder in Tablet Formulations: Gellan Gum is employed as a binder in tablet formulations, contributing to the mechanical strength and integrity of the tablets.
7. Thickening Agent: It is used as a thickening agent in liquid and semi-solid pharmaceutical preparations, improving their consistency and ease of administration.
8. Film-Forming Agent: Gellan Gum is utilized as a film-forming agent in the production of pharmaceutical films or coatings, contributing to the overall stability and appearance of the dosage form.
9. Texturizer in Oral Disintegrating Tablets: In the development of orally disintegrating tablets, gellan gum may be used as a texturizer to enhance the disintegration properties and mouthfeel.
10. Gelling Agent in Topical Applications: Gellan Gum is employed as a gelling agent in topical formulations such as gels and creams, providing a desirable texture and facilitating the application of the product.

The versatility of gellan gum makes it a valuable ingredient in various pharmaceutical formulations, contributing to the overall efficacy, stability, and patient acceptability of medicinal products. As the industry continues to explore novel drug delivery systems and formulations, the use of gellan gum is expected to evolve and expand.

Factors to consider when selecting Gellan Gum Excipients

When selecting gellan gum as an excipient in pharmaceutical formulations, several factors should be considered to ensure its suitability for the intended application. These factors include:

1. Compatibility with Active Ingredients: Gellan Gum should be compatible with the active pharmaceutical ingredients (APIs) in the formulation. It is essential to assess potential interactions that may affect the stability or efficacy of the drug.
2. Rheological Properties: Gellan Gum is known for its unique rheological properties, including gelling and thickening abilities. The desired rheological behavior, such as viscosity and gel strength, should align with the specific requirements of the pharmaceutical formulation.
3. Solubility and Dispersion Characteristics: The solubility and dispersion characteristics of gellan gum are important considerations. The excipient should dissolve or disperse readily in the chosen solvent or dispersion medium to achieve uniform distribution in the formulation.
4. pH Sensitivity: Gellan Gum exhibits sensitivity to pH changes. It is crucial to consider the pH range of the pharmaceutical formulation and ensure that gellan gum remains stable within that range to avoid unintended changes in viscosity or gelation.
5. Temperature Sensitivity: The temperature sensitivity of gellan gum is another important factor. Some formulations may undergo changes in viscosity or gel strength based on temperature variations. Understanding these temperature-dependent properties is essential for the stability of the final product.
6. Gelling Characteristics: If the intended application involves the formation of gels, the gelling characteristics of gellan gum should be evaluated. The concentration of gellan gum and the method of gel formation can influence the texture and performance of the gel.
7. Dosage Form Requirements: Consideration should be given to the specific requirements of the dosage form. For example, gellan gum can be used in oral liquids, suspensions, gels, tablets, and other formulations. The excipient’s physical and chemical properties should align with the desired characteristics of the dosage form.
8. Regulatory Compliance: Gellan Gum used in pharmaceuticals should comply with regulatory standards and pharmacopeial monographs, such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP). This ensures the excipient’s quality, purity, and safety.
9. Manufacturability: The ease of manufacturing, including factors such as mixing, processing, and compatibility with other excipients, should be considered to ensure a smooth and efficient production process.
10. Cost and Availability: Practical considerations such as cost and the availability of gellan gum in the required quantity should be taken into account, balancing the performance of the excipient with economic considerations.

By carefully evaluating these factors, pharmaceutical formulators can make informed decisions about the selection and use of gellan gum as an excipient in their formulations. This ensures that the excipient contributes positively to the overall quality and stability of the pharmaceutical product.

 

 

 

Definitions according to the USP/NF

The United States Pharmacopeia-National Formulary (USP-NF) has established standards for gellan gum to ensure their quality and safety in pharmaceutical applications.

USP-NF Monograph for Gellan Gum:

• CAS Number: 71010-52-1
• Description: Gellan Gum is a high-molecular-weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Pseudomonas elodea, purified by recovery with isopropyl alcohol, and then dried and milled. It is a heteropolysaccharide comprising a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucose units. The glucuronic acid is neutralized to mixed potassium, sodium, calcium, and magnesium salts. It may contain acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. It yields NLT 3.3% and NMT 6.8% of carbon dioxide, calculated on the dried basis.

Gum Excipients on pharmaexcipients.com – in alphabetical order

Product	Manufacturer
Aquacoat ARC	IFF
Avicel CE-15	IFF
AVICEL CL-611	IFF
CEKOL® 150	CPkelco
CEKOL 2000 P	CPkelco
CEKOL® 2000 P	CPkelco
CEKOL® 30000 P	CPkelco
GRINDSTED® Xanthan 80 PRM Plus	IFF
GRINDSTED® Xanthan Clear 80 PRM	IFF
GRINDSTED® Xanthan Easy PRM	IFF
GRINDSTED® Xanthan Gum	IFF
HiCel CE-15	SIGACHI®
KELCOGEL® CG-HA	CPkelco
KELCOGEL® CG-LA	CPkelco
SEPISMART™ SR	SEPPIC
XANTURAL 11K	CPkelco
XANTURAL 180	CPkelco
XANTURAL 75	CPkelco