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A nanoparticle exogenous protein free micronutrient added pulmonary surfactant composition for neonatal respiratory distress syndrome (NRDS) and a process for preparing the same

Dr. Rinti Banerjee at IITB has invented a process and formulation of a nanoparticulate exogenous micronutrient with added protein-free surfactant composition for use in treating Neonatal Respiratory Distress Syndrome (NRDS). During NRDS children do not produce natural surfactants and breathing and the exchange of gases becomes difficult as the lung surface sticks to each other. Hence, a surfactant is needed to aid proper alveolar function. The composition developed contains nanovesicles of one phospholipid and a natural oil selected from clove or eucalyptus oil; micronutrients selected from ascorbic acid and soluble calcium salts. This composition is cost effective, does not have the side-effects than normally seen when animal derived protein containing surfactants, and also can be used to deliver essential micronutrients for premature babies' lungs.

A solution of phospholipid (dipalmitoyl phosphatidyl choline or PC), surfactant in an organic like solvent chloroform is prepared and dried under vacuum, with pH adjusted to 7.40. Aqueous isotonic electrolyte solution containing micronutrients selected from soluble calcium salt, ascorbic acid and natural oils selected from clove oil or eucalyptus oil are added and allowed to hydrate for about an hour. The preferred ratio of PC to eucalyptus oil or clove oil in a ratio of 10:3w/v along with 0.1 parts of ascorbic acid. The Preferred composition has particle size 150 to 450 nm in diameters. The formulation can be inhaled easily, disperses uniformly, acts as a delivery system for micronutrients and is easily prepared. The prepared surfactant formulation was found to be better than known surfactants. The main parameters for a surfactant to be effective in NRDS are minimum surface tension on film compression < 5mN/m, low surface tension on adsorption 25 to 30 mN/m and low compressibility. These were surpassed by the formulation. The cost effectiveness and easy delivery by nebulization make this invention a valuable asset in medical treatment of NRDS.

A similar invention relates to an exogenous protein free pulmonary surfactant composition for treating adult respiratory syndrome (ARDS) which comprises one phospholipid and a natural oil namely eucalyptus oil. Similar to the first formulation PC or dipalmitoylphosphatidylcholine is dissolved in an organic solvent in an organic solvent and dried under vacuum at 40 C, with pH adjusted to 7.40. A Calcium free aqueous isotonic electrolyte solutions is prepared by adding eucalyptus oil and is hydrated in a rotary vacuum evaporator for a period of 1 hour at 37 C. The preferred composition may have a dipalmitoyl posphatidylcholine to eucalyptus oil ratio of 2:1 or 1:1 w/v. This formulation is unique as it prevents the interaction between surfactant and the hematological agents and hence overcomes inhibition achieving a function which is as good as natural surfactants in the absence of inhibitors.

Efficacy of this composition has been tested and is found to be better than the known artificial surfactants. The parameters for a surfactant to be effective for ARDS are preventing interaction between surfactant and hematological agents, achievement of low minimum surface tension in the presence of hematological agents like erythrocyte membranes, low compressibility in the presence of hematological agents like erythrocyte membranes, requirement of a minimal area change for achievement of low surface tension in the presence of hematological agents like erythrocyte membranes. The composition invented to treat ARDS fulfills all these conditions, and is an important cost effective achievement in medical science.

Indian patent application no. 1222/MUM/2005 Patent grant no. 241271
Inventors: Rinti banerjee, Rachana, J Bellare, and R Puniyani