A Novel Fast Dissolving/Fast Disintegrating Tablet (FDDT) Technology


Oral delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance.
The tablet is the most widely utilised oral dose format. A novel tablet concept which offers ease of oral administration and benefits of increased patient compliance is the fast dissolving/disintegrating tablet (FDDT). This tablet format is designed to allow administration of an oral solid dose form in the absence of water or fluid intake. Such tablets readily dissolve or disintegrate in the saliva generally within <60 seconds. A number of FDDTs are commercially available for human use using technologies developed by pharmaceutical companies such as Cardinal Healthcare, Jannsen Pharmaceutical, Bioavail,, Eurand Yamanouchi. However, these technologies use either expensive processing technology producing fragile tablets that require costly specialised packaging or use conventional tabletting procedures which give longer than desired disintegration & still require specialised packaging.
Dr Zeibun Ramtoola and her team at the Royal College of Surgeons in Ireland have addressed the above shortcomings by developing a novel, cost effective one step FDDT manufacturing process using conventional tabletting technology for the production of robust tablets suitable for conventional packaging. This proprietary technology is applicable to a wide range of therapeutic agents including generics, thereby adding value, i.e. 'supergenerics' for veterinary or human application.
The oral drug delivery market was estimated to be worth $35bn in 2006 & forecast to reach $52bn by 2010 with a CAGR of 10%. Of this, the FDDT, taste masked & micro emulsion formulation segments constitute a 22% share with an expected CAGR of 17% to 2010. There is a clear opportunity for new enhanced oral products arising within this market segment.

Background
Approximately one-third of the population, primarily the geriatric and pediatric populations, has swallowing difficulties, resulting in poor compliance with oral tablet drug therapy which leads to reduced overall therapy effectiveness. A new tablet dosage format, the fast dissolving tablet has been developed which offers the combined advantages of ease of dosing and convenience of dosing in the absence of water or fluid. These tablets are designed to dissolve or disintegrate rapidly in the saliva generally within <60 seconds (range of 5-50seconds). Due to the constraints of the current FDDT technologies as highlighted above, there is an unmet need for improved manufacturing processes for fast dissolving tablets that are mechanically strong, allowing ease of handling and packaging and with production costs similar to that of conventional tablets.

Technology Description/Development Stage
Formulation advances using a conventional tabletting process have led to the development of mechanically robust tablets which readily dissolve/disintegrate within <50 seconds and can be formulated in a range of sizes from 10 -15mm. The tablets produced are stable, and can withstand shipment in conventional tablet containers without loss of integrity.
Pre-clinical canine studies with a range of formulations have demonstrated palatability and ease of administration.
A number of FDDT products for human and veterinary administration are currently under development by the RCSI team for the delivery of water soluble as well as lipophilic drug compounds.

Competitive Advantage and IP Status
Lower production, packaging and distribution costs compared to current commercially available products
The technology is versatile and suitable for the development of enhanced products for veterinary medicines, OTC ,Rx medicines & line extensions
The new proprietary method allows the incorporation of microencapsulated drugs for enhanced bioavailability, flexibility of dosing & immediate and/or controlled release for superior therapeutic benefit

IP Status
Patent applications have been filed in 2007 at the EPO & the USPTO to protect this technology and concurrent products

Type of Business Sought
This technology opportunity is available for discussion with investors or other potentially interested licensees /co-development partners.

Principal Investigator:
Dr Zeibun Ramtoola, Royal College of Surgeons.

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RCSI is the owner of all IP.

EI Bio works in partnership with RCSI to commercialise the technology