Developing GMP Xyloglucan as NextGen pharma super-excipient

Allschwil, Switzerland: – Pharmatrans SANAQ is investigating the development of GMP-grade xyloglucan as a potential pharmaceutical ‘super excipient’ that will promote far more targeted and bioavailable drugs.

Xyloglucan is a plant-based polysaccharide, typically derived from tamarind seeds, has extremely useful film-forming, mucoadhesive, and thickening properties. These characteristics support multiple functional pharma excipient roles, such as stabilizer, binder, viscosity modifier, or controlled-release matrix.

However, to realize the full therapeutic potential of xyloglucan, it has now become a pharmaceutical priority to move it beyond GRAS (Generally Recognized as Safe) regulatory status for use in medical devices to a full GMP certified product with pharmacopeial recognition.

Xyloglucan properties and potential

The unique physicochemical properties of xyloglucan make it a promising candidate for pharmaceutical applications. Its non-toxicity, biocompatibility, biodegradability, and mucoadhesive characteristics have led to use of GRAS-grade Xyloglucan as a protective barrier on mucosal surfaces in medical devices for applications such as eye drops, nasal sprays, and wound dressings.

Potential uses of Xyloglucan extend much further into pharmaceutical applications involving systemic drug delivery or internal formulations. These opportunities include:

• Controlled Drug Release: Xyloglucan-based matrices or coatings can modulate the release rate of drugs to optimize therapeutic efficacy and reduce dosing frequency.
• Mucoadhesive Drug Delivery Systems: Xyloglucan’s strong mucoadhesive properties facilitate prolonged contact with mucosal surfaces (e.g., oral, nasal, ocular, vaginal), enhancing drug absorption and bioavailability.
• Targeted Drug Delivery: Xyloglucan can be modified or conjugated with targeting ligands to direct drugs specifically to diseased cells or tissues.
• Wound Healing: Xyloglucan promotes wound healing by providing a moist environment, stimulating collagen synthesis, and reducing inflammation.
• OSD Formulations: Xyloglucan can be used as a binder, disintegrant, or film former in oral solid dose formulations to improve tablet mechanical strength, disintegration profile, and drug release characteristics.
• Probiotic Delivery: Xyloglucan’s film-forming properties make it an excellent encapsulating agent for probiotics, ensuring their survival through the harsh conditions of the stomach and delivering them effectively to the gut.

The Importance of GMP-Grade Xyloglucan

GRAS-grade Xyloglucan is acceptable for certain medical devices and has received FDA approval as a food additive. A team of formulators at Switzerland’s renowned Basel University has been able to take advantage of GRAS status to begin developing a Xyloglucan-derived excipient for animal health products but human pharmaceutical applications demand far higher levels of assured quality, consistency, purity, and safety.

GMP compliance would allow all the opportunities listed above to be realized, thanks to:

• Purity and Consistency: Elimination of contaminants, batch-to-batch consistency.
• Traceability: Comprehensive documentation of the entire manufacturing process.
• Quality Control: Rigorous testing at every stage of production.
• Patient Safety: Minimization of risks associated with adverse reactions or impurities.
• Regulatory Compliance: Adherence to international standards required for pharmaceutical approval.

New pharma opportunities

Ensuring the purity, consistency, and regulatory compliance of GMP-grade Xyloglucan would then open the way to a whole new range of pharmaceutical products that could include novel drug delivery systems with improved efficacy and patient compliance, targeted therapies with reduced side effects, advanced wound care products with enhanced healing properties, Innovative OSDs with superior performance and high-quality probiotic supplements with improved delivery to the gut.

Therefore, there is a very strong business case for researchers to focus on new pharmaceutical applications of GMP-grade Xyloglucan 3 and for pharma companies to invest in the use and sourcing of what has potential to become a super-excipient.

About Pharmatrans-SANAQ

Founded in 1982 and headquartered at Allschwil, near Basel, Switzerland, Pharmatrans SANAQ AG is a pharmaceutical distributor that specializes in marketing and promotion of excipients and Innovative ingredients. It also provides its own formulation expertise to give customers a complete portfolio of technical and smart solutions for the formulation development and manufacture of solid and semisolid dosage forms.

Pharmatrans SANAQ offers innovative solutions based on a safe analytical and quality (SANAQ®) approach, leveraging solid experience, industrial know-how, regulatory skills, strategic partnerships with R&D centers, collaboration with international universities and in-house expertise from its team of formulator scientists to deliver support in the excipients field from basic materials to ready-made products for customized solutions.

Pharmatrans SANAQ offers a wide range of specialized pharmaceutical excipients that include microcrystalline cellulose (MCC), tartaric acid pellets (TAP), sugar spheres, Mannitol pellets, calcium carbonate pellets, silicon dioxide pellets and co-processed excipients.

Pharmatrans also develops specific tailored products based on specific customer requirements, process technology and applications. To do this, Pharmatrans works in close partnerships with an international network of advanced, selected, and qualified CMO and CDMO developers and manufacturers, several of whom hold significant international and local process patents.

Further information at: www.pharmatrans-sanaq.com

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