Gato del Monte A, Gómez CM, Morales LI, Romero DJA, Bellma MA, Botet GM

Language: Spanish
References: 9
Page: 471-479
PDF size: 67.64 Kb.

ABSTRACT

The development of a 2 % dorzolamide eye solution to treat patients with ocular hypertension, having open angle glaucoma, pseudoexfoliative glaucoma and other secondary open-angle glaucoma began with the study of the formulation components by replacing some excipients stated in the reviewed literature, and the physical, chemical, biological, microbiological and rheological properties were analyzed during the pre-formulation studies. An analytical technique was devised for the finished product. Three batches of formulation were prepared and then stored in low density polyethylene flasks with Master Batch of 5 ml capacity, manufactured in situ by the Bottle Pack filler. These reservoirs were exposed at 30 ± 2 °C room temperature for 24 months and at 40 ± 2 ºC accelerated temperature for 6 months and relative humidity of 75 %, according to the requirements set by the State Center for Drug Control. At the beginning and at the end of the microbiological study, there was proved the sterility of each batch, the achieved results were satisfactory. After complying with all described quality parameters, the drug was registered in the Cuban regulatory body for its safe use in the treatment of the above-mentioned diseases. This drug is being manufactured at industrial level and thus marketed.

REFERENCES

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