Development of preservative-free artificial tears, ophthalmic solution

Abstract

Translator      

Hypromellose, in ophthalmic solution, has the purpose of increasing the humidity of the ocular surface, lubricating the blinking movement and reducing the symptoms of the patient affected by dry eyes syndrome. The National Health System does not have a formulation of artificial tears, without a preservative, in single-dose bottles, for the treatment of this pathology. The objective of this work was to develop a preservative-free artificial tear formulation of pharmaceutical quality. A formulation similar in composition to human tears was developed. Once the controls of the three pilot batches prepared were approved, they were formed, dosed and sealed in the Bottelpack TYP 321 machine, in transparent vials of 0.5 mL capacity. The operating parameters were verified and the quality control of the batches was carried out. The parameters evaluated during scaling demonstrated that each of the technological processes involved in obtaining the ophthalmic solution, such as speed and time of agitation, dissolution, pH and filtration, met the established requirements. The sterility of the product was guaranteed by sterilizing filtration, carried out during the filling process of the ophthalmic solution, demonstrating the integrity of each of the membranes used, in each type of filter used in the production process. The evaluation of the physical, chemical and microbiological parameters demonstrated the quality of the newly prepared batches. The reproducibility of the manufacturing process of preservative-free artificial tears is demonstrated, in single-dose vials, according to the existing conditions at the UEB Julio Trigo López Laboratory.