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Innovation
Sol-Gel™ – Ophthalmology
Sol-gel™: a patented technology for formulating ophthalmic hydrogels
Sol-gel™ is a patented technology for formulating ophthalmic hydrogels. It has the particularity of being completely liquid during manufacture and of gelling on application, more precisely on contact with the tear fluid, thanks to the gellan gum they contain.
The increase in viscosity in situ provides optimal patient comfort and extends the length of time that the ophthalmic drug acts; this allows a reduction in the amount of active ingredient delivered at each intake, thereby limiting potential undesirable side effects.
Benefits
- Optimisation of diagnostic and pre-operative mydriasis induction
- High bioavailability
- Easy administration
- Prolonged release
- Improved ocular residence time
- Reducing the required amount of active pharmaceutical ingredients administered by 4 to 8 compared to the conventional eye drop regimen
- Molecules: hydrophilic excipients and compendia
Technology
- Blow-Fill-Seal (BFS) or Preservative-free multidose (PFMD)
- Preservative-free
- Sterile
Product
Solmyd™ is the first application of our Solgel™ technology; it is a mydriatic hydrogel to optimize the induction of diagnostic and pre-operative mydriasis, which contains a combination of tropicamide and phenylephrine hydrochloride.
The pupil must be dilated (Mydriasis) prior to many ocular examinations and operations.
As of today, only mydriatic solutions are available; they require repeated instillations every few minutes, which is restrictive for patients and healthcare professionals.
Solmyd™ achieves mydriasis with a single instillation. The concentrations of tropicamide and phenylephrine hydrochloride in the drops are reduced compared to existing eye drops, reducing the adverse (cardiac) effects of phenylephrine on the heart and providing a single dosage for adults and children.
Scientific Publications
Research work has been carried out jointly with Unither’s teams and those of AGEPS, the «Agence Générale des Equipements et Produits de Santé, AP-HP», and the «Unité de technologies chimiques et biologiques pour la santé, Université de Paris, CNRS, INSERM, Faculté de Pharmacie». So far 6 international scientific publications dedicated to Sol-Gel™ technology have been published.
- Influence of additives on a thermosensitive hydrogel for buccal deliveryof salbutamol: Relation Between micellization, gelation, mechanic and release properties
- Poloxamer bioadhesive hydrogel for buccal drug delivery: Cytotoxicity and trans
epithelial permeability evaluations using TR146 human buccal epithelial cell line - In vitro and in vivo evaluation of in situ gelling systems for sustained topical ophthalmic delivery: state of the art and beyond
- Cyanine derivative as a suitable marker for thermosensitive in situ gelling delivery systems: In vitro and in vivo validation of a sustained buccal drug delivery
- Novel in situ gelling ophthalmic drug delivery system based on gellan gum and hydroxyethylcellulose: Innovative rheological characterization, in vitro and in vivo evidence of a sustained precorneal retention time
- In Situ Gelling Ophthalmic Drug Delivery System for the Optimization of Diagnostic and Preoperative Mydriasis: In Vitro Drug Release, Cytotoxicity and Mydriasis Pharmacodynamics
Authorizations
All French sites are subject to inspections by European authorities, in order to manufacture products for the European markets. The Coutances site (France) is regularly inspected by the ANSM (Agence Nationale de Sécurité du Médicament), the FDA (Food Drug and Administration), ANVISA (Brazilian Agency) and other health authorities around the world.
Manufacturing plants
Coutances, France