[Guest]

Hello, everyone,

I hope you are all doing well ^^

I've this problem in my Pharmaceutics course, It says:

=============================================================

A pharmaceutical manufacturer is planning to market a topical powder consisting of an antifungal agent in an inert powder vehicle. However, the pilot plan scale up, assay of the containers revealed that they did not have a uniform potency of the antifungal active ingredient. The USP 32-NF 27 mono graph for a typical antifungal topical powder states that it is to contain not less than 90.0% and not more than 110.0% of the labeled amount of the active drug. This problem has to be corrected before the product can proceed to full scale manufacturing.

The antifungal occurs as a white or nearly white crystalline powder with not more than a slight odor. It is only very slightly soluble in water and in ether and slightly soluble in alcohol. It has a true density in the range of 4.5 g/ml to 5.0 g/ml and apparent density of 0.12 g/ml. It was sifted through a 40-mesh sieve prior to blending. The inert vehicle is talc that occurs a s a very fine white or grayish-white crystalline powder. It is unctuous, adheres readily to the skin and is free of grittiness. It is practically insoluble in dilute acids and alkalis, organic solvents and water. It has a true density in the range of 2.7 to 2.8 and an apparent density of 0.05 g/ml. It has a specific surface area of 2.41 to 2.42 m²/g

the powders are weighed and blended in a large V-blender. The powder is then moved to the hopper of a large packaging device. The machine vibrates significantly during the packaging.

What is the plan to solve this problem?

===========================================================

I tried to solve it by looking up information from Industrial pharmacy textbooks,

and most of them explaied the proper mixing to get a uniform powder, but non of the ones I seeked explained anything about the solution when you get a non-uniform mixture !!

If anyone has any idea, please post it here ^^

ThankYou

[plasmid]

Hello, everyone,

I hope you are all doing well ^^

I've this problem in my Pharmaceutics course, It says:

=============================================================

A pharmaceutical manufacturer is planning to market a topical powder consisting of an antifungal agent in an inert powder vehicle. However, the pilot plan scale up, assay of the containers revealed that they did not have a uniform potency of the antifungal active ingredient. The USP 32-NF 27 mono graph for a typical antifungal topical powder states that it is to contain not less than 90.0% and not more than 110.0% of the labeled amount of the active drug. This problem has to be corrected before the product can proceed to full scale manufacturing.

The antifungal occurs as a white or nearly white crystalline powder with not more than a slight odor. It is only very slightly soluble in water and in ether and slightly soluble in alcohol. It has a true density in the range of 4.5 g/ml to 5.0 g/ml and apparent density of 0.12 g/ml. It was sifted through a 40-mesh sieve prior to blending. The inert vehicle is talc that occurs a s a very fine white or grayish-white crystalline powder. It is unctuous, adheres readily to the skin and is free of grittiness. It is practically insoluble in dilute acids and alkalis, organic solvents and water. It has a true density in the range of 2.7 to 2.8 and an apparent density of 0.05 g/ml. It has a specific surface area of 2.41 to 2.42 m²/g. The powders are weighed and blended in a large V-blender. The powder is then moved to the hopper of a large packaging device. The machine vibrates significantly during the packaging.

What is the plan to solve this problem?

===========================================================

I tried to solve it by looking up information from Industrial pharmacy textbooks,

and most of them explaied the proper mixing to get a uniform powder, but non of the ones I seeked explained anything about the solution when you get a non-uniform mixture !!

If anyone has any idea, please post it here ^^

ThankYou

I suspect that the points in green are the key ones. I don't know anything about pharmaceutical production, so I don't know what size of particle will be made by sifting through a 40 mesh seive, and whether or not you can calculate the particle size of the talc based on its specific surface area and density. That will be your homework task. If you can calculate them and show that the particle sizes are very different, then the vibration of the packaging machine that comes after the two have been blended could explain the mixture's non-homogeneity.