Product development
We develop proprietary and differentiated drugs in core therapeutic areas of pain, addiction and critical care through our own in-house product development and in partnership with innovative companies.
OUR EXPERTISE
We have specific expertise in the development of opioids high potency products for treating cancer-related pain which requires specialised, highly technical knowledge to formulate and manufacture the active substances used in these products. Our expertise enables us to develop products such as Fentanyl for the relief of severe pain for which these molecules are particularly effective.
Over the last 40 years, Ethypharm has registered an important range of new products which are now being commercialised worldwide.
OUR TECHNOLOGIES
TASTE MASKING & THE ORODISPERSIBLE FORM – Flashtab / T-Mask®
These drugs dissolve quickly in the mouth and can be taken with or without water. They take the form of tablets or thin films. The Flashtab® orodispersible version contains agents to mask the taste of the active ingredient, sweeteners and flavorings.
AMELIORATION OF BIOAVAILABILITY
Sublingual and oral technologies – These tablets or thin films release the active substance directly in the mouth where they are absorbed, permitting rapid action and limitation of active substance degradation.
Drugsol® – This technology group improves the bioavailability of barely soluble molecules
MODIFIED RELEASE BY THE ORAL ROUTE
Locktab® – Difficult to crush or bite into, these tablets are designed to prevent both accidental misuse and intentional misuse by patients especially suitable for preventing the misuse of opiates and other narcotics.
Multicaps® – Presented in capsule or tablet form, these micro-granules are formulated to allow targeted release of the active ingredient. This can be extended or controlled release (gastro-resistant forms or colonic delivery). The technology also combines diverse active substances or diverse release rates for a same active substance.
REGULATORY AFFAIRS
Ethypharm, is subject to many regulations designed by health authorities to protect public health and ensure safety and efficacy of drugs in humans. In this highly regulated environment, the Regulatory Affairs department plays a crucial role.
It ensures the compliance of Ethypharm’s products with the current regulations and the maintenance of the marketing licenses.
It is involved in all stages of the product life from development to post-marketing stage.
Externally, it is the key interface between the company and the health agencies. Internally, it liaises at the inter-phase of drug development, clinical development, manufacturing, pharmacovigilance, marketing and business development, in order to meet regulatory commitments with the health authorities and provide strategic advice.
HIGH CONTAINED DEVELOPMENT AREA FOR CATEGORY 3 PRODUCTS (ONCOLOGY) AND HIGH CONTAINED EQUIPMENT (GRANULATION, TABLETTING, AND ENCAPSULATION)
At Ethypharm we develop products that require very high level of manipulation such as very strong opioids and anti-cancer generic drugs.
Ethypharm has a specific zone capable to receive and to make the treatment of these active products safely for our employees.
This module has been designed for the development and production of active products where 5 work areas allow us to handle different Active Pharmaceutical Ingredients (APIs) in simultaneously.
PHARMACOKINETICS
Pharmcokinetics and biopharmacy play a key role in pharmaceutical project development and especially in the area of complex formulation or active ingredient drugs development.
The Pharmacokinetic teams are deeply involved at all the stages of the product development.
The team also designs, runs and analyses the Pharmacokinetics and bio-equivalence studies required to achieve the marketing authorisation for Ethypharm’s products.