Quality Evaluation Dosage

The dosage of a sprayer refers to the delivered volume in one spraying. Normally, sprayers applied for nasal, mouth, and throat sprays have the requirement of dosage, while sprayers applied for skin sprays or other non-pharmaceutical sprays don’t require the dosage is very accurate.

The widely applied dosages in pharmaceiutcal sprays include 0.10ml, 0.14ml, 0.07ml and 0.05ml. A point necessary to be noted. These dosages are tested using pure water. For some viscous liquids, the dosages may be different.

The dosage can not be so accurate without any deviation. Therefore, error or tolearance should be given along with the delivered volume. Different pharmacopeia gives the standards of error from +/- 25% to +/- 15%. However, current technology can reach the level of the error +/- 10%.

It is not the delivered amount meet the designed dosage range from the first spray for a new pump. For a new pump, first sprays will fill the inner channel fully, and then the delivered amount will be in the dosage range. The number of these first sprays is called priming times. Normally priming is 5 to 6 times. If priming times is more than 10, the sprayer quality can not be accepted.

The stability of priming spray volume refers to the delivered amount of a used sprayer after standing for some time. In detail, a sprayer is sprayed and the delivery amount already reaches the dosage range. Then stand this sprayer for one day or longer time, and tested the first delivered amount again. If the first delivered amount is still in the range of dosage, we can say the priming spray volume is stable. The reason we concern the stablity of the priming volume is a bottle of liquid can not be finished by spraying continuously in a short time. For example, the medicine direction often likes 2 sprays once and 3 times per day. Therefor we must assure the delivered amount be in the dosage range at any time the medicine is delivered. Normally 2 to 3 days stablity of priming spray volume is enough. A point is needed be clarified for this curve. The days in the horizontal axis means the days after the last spray instead of the days after the first spray. It means test is performed a the 1, 3, 6, 10…… days instead of at the 1, 2, 3, 4……days.

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