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Innovative Galenical Formulations
Drug Delivery Systems
In addition to marketing authorizations and the technical and industrial files relating thereto, CLL PHARMA's intellectual assets include 80 international patents concerning 5 different Drug Delivery Systems (new drug administration technologies) applied to molecules worth 8.5 billion Euros per year in net sales.
The market for innovative galenical formulations
After many years as pharmaceutical R&D's poor relation, innovative galenical formulations have been making great strides over the past 20 years.
Long regarded as a mere presentational adjunct to the active ingredient, the galenical formulation has become an essential component of therapeutic efficacy. It aims to manage the active ingredient at the optimum concentration to:
- ensure the best therapeutical efficacy at the lowest possible dose
- improve tolerance
- promote patient compliance (following the treatment) by reducing the number of doses taken daily.
Galenical innovation is a logical extension of generic drug development work. It provides many answers to the pharmaceutical industry's present problems, such as:
- competitive differentiation
- extension and renewal of a product's life cycle
- range diversification or extension
- reduced costs and high return on investment
- low financial risks.
CLL PHARMA's proprietary technologies
CLL PHARMA's portfolio includes five proprietary Drug Delivery technologies, patented until 2017-2020, with a virtually unlimited field of application to known molecules and new substances.
The system is based on manufacturing microbeads of a pharmaceutical composition by means of an atomization process to enhance absorption of poorly soluble lipophilic active ingredients.
CelAtom® Technology is applied to the following active ingredient :
- Fenofibrate
CLL PHARMA has applied this technology to four active ingredients:
- Isotretinoin
- Fenofibrate
- Simvastatine
This technology makes it possible to provide active ingredients in the form of tablets that can be dispersed in a glass of water, making administration easier. It is applied to well-known macrolide antibiotics such as:
- Azithromycin
- Spiramycin
- Spiramycin-Metronidazole
The technological basis is a process by which an active principle with little or no natural solubility in water can be made water-soluble.
This technology has the advantage of providing users with dry pharmaceutical compositions (individual sachets) as opposed to the pharmaceutical forms presently on the market (multidose bottles of hydroalcoholic solution).
This technology is usefully applied for the replacement of mouthwash solutions by individual sachets designed to be dissolved in a glass of water at the time of use, such as essential oils-based mouthwash products.
This invention relates to galenical forms that disintegrate quickly in the mouth. Most oral forms (tablets, capsules, oral suspensions, syrups, etc.) require a liquid to make them easier to swallow; however, there are many situations where it may be useful to be able to take a drug without needing to take any liquid with it.
It is therefore useful to try to provide a formulation which, when placed in the buccal cavity, will disintegrate quickly on contact with saliva to produce a suspension that is easily swallowed or absorbed through the oral mucosa.
The FastOral® technology is applied to analgesics such as:
- Mirtazapine
- Tramadol
- Tramadol-Paracetamol
- MIDDS® Technology (Micellar Improved Drug Delivery Solution)
This technology is aimed at increasing intestinal absorption of poorly soluble lipophilic active ingredients and thus improving their efficacy by lowering the doses administered. It uses a combination of amphiphilic solvents leading to solubilization of the active ingredient in presence of an aqueous phase and the formation of a nanoemulsion by the formation of droplets (micellae) with dimensions close to 100 nanometers (0.1 micron). The finished drug is dispensed in a softgel capsule or as an oral or injectable solution.
CLL PHARMA has applied this technology to four active ingredients:
- Fenofibrate
- Isotretinoin
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