Specialty Technologies

Mayne Pharma’s oral drug delivery technology experience has been established across a number of therapeutic classes. Through specialist material science skills, processes and proprietary technologies, clients are provided with products that have developmental, regulatory and marketing exclusivity.

Mayne Pharma’s oral drug delivery technologies and skills can be applied to reformulate solid oral dose forms of branded prescription products, generic prescription products, branded over the counter products and value added active pharmaceutical ingredients (APIs). Proprietary pharmaceutical technologies include:

• Customized controlled-release drug delivery
• Bioavailability enhancement
• Taste masking (liquid and solid presentations)

Through our collaboration with our commercial partners, these technologies are utilized to develop and distribute novel prescription and OTC products which offer advantages over existing products, in order to meet unmet medical needs.

When applied appropriately, these technologies can potentially deliver the following therapeutic and convenience benefits to patients:

• Reduced dosing frequency
• Increased patient compliance
• Improved side effect profile
• More constant therapeutic effect

Improving clinical outcomes & maximizing returns

Drug reformulation of existing molecules plays a key role in improving patient compliance and improving clinical outcomes. It also enables a molecule’s full commercial potential to be recognized. As such it is vital in maximizing returns on investment.

Key objectives of drug reformulation include:

• Extending the scope of the drug (i.e. indication, routes of administration)
• Improving efficacy
• Improving ease of administration
• Extending patent life
• Improving the product’s competitive profile

Revitalizing your Product

Drug reformulation reveals a number of marketing opportunities at different stages of the product lifecycle that help to achieve strategic goals. Employing Mayne Pharma’s proprietary technology to manage the product life cycle may allow opportunities for new regulatory exclusivity and intellectual property, and hence extend the period of marketing exclusivity for the product while providing additional patient benefits.

Product lifecycle opportunities include:

• Increased commercial potential of a molecule is enabled through expanding the scope (i.e. new indications, accessing new segments of patient populations).
• New sales opportunities enabled by new and differentiated formulations.
• Extended patent protection for a competitively differentiated formulation.
• Reformulation of an off patent drug to capture market share and/or grow the market for the drug.

Maximizing returns on new chemical entities (NCE)

Many NCEs fail to reach the market as an oral dose form due to inadequate physicochemical or biopharmaceutical properties (e.g. high variability and/or low absorption, short half life etc). This results in candidate failure or development of the NCE in a less preferred route.

Such deficiencies may be addressed with the application of Mayne Pharma’s drug delivery technologies, which can help to diminish such inadequacies, formulate a NCE into a preferred route and allow for NCE optimization.