Scientists at Sami Labs Limited have developed a stable formulation of forskolin eye drops for use in the management of ocular hypertension and glaucoma. The company is in the process of filing an Investigational New Drug (IND) application for this product in India . Hoechst India Ltd (now Aventis) had originally filed an IND application for evaluating forskolin eye drops for the same indication viz. ocular hypertension and glaucoma, in 1983. Sami Labs will be the second applicant, and plans to conduct multicenter clinical trials (in 6 centers with a total of at least 100 patients) as part of the IND protocol.
Forskolin is insoluble in water and therefore difficult to formulate into clear compositions for ocular application. The patent pending forskolin eye drops composition from Sami Labs contains natural forskolin from Coleus forskohlii solubilized in water using an innovative method.
2. Psoriasis support composition
Scientists at Sami Labs developed a patent pending combination treatment for psoriasis. The regimen entails internal administration of a phytonutrient-mineral composition along with the application of a topical cream containing selected phytonutrients.
Preliminary laboratory data were encouraging and an IND application for this regimen is in the process of being filed in India . Multicenter trials on at least 100 psoriasis patients form part of the protocol. The study will be conducted at centers in various climatic zones in the country, to enable determining the efficacy of the formulation in subjects exposed to diverse atmospheric temperature and humidity parameters.
