Continuous Granulation

Overview

Granulation is a process of powder size enlargement to granules, rendering them into a free-flowing state which improves flowability and compressibility.

It ensures that all the neccessary ingredients and Active Pharmaceutical Ingredient (API) are mixed thoroughly and a uniform distribution of each ingredient throughout the mixture is achieved and hence there is no segregation of powder into individual components.

Esco Aster is now expanding its territories in producing granules with enhanced uniformity of API in the drug product with other associated advantages such as increase in the blend density, increased ease of metering or volumetric dispensing and minimal or no toxic exposure and other hazards pertaining to the processes involved.

Granulation ensures that all the neccessary ingredients and Active Pharmaceutical Ingredient (API) are mixed thoroughly and a uniform distribution of each ingredient throughout the mixture is achieved and hence there is no segregation of powder into individual components.

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One key aspect in granulation is the effective usage of expensive APIs in small quantities for a good process development leading to an effective mass production.

A batch process granulation would require several batch processors/equipments in parallel with a higher capital investment.

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Advantages of Continuous Granulation:

  1. Less usage of APIs leading to significant savings in cost and time
  2. Usage of a same equipment for small volume production for clinical studies as well as for a full production scale by extending the run time or by varying the parameters linearly depending on the scale
  3. Flexibility in terms of equipment usage thereby eliminating technology transfer and other problems associated with scale-up.
  4. Overall reduction in man power and equipment expenses providing a great opportunity for improving overall equipment effectiveness (OOE).
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What We Do

At Esco Aster, we are interested in developing continous granulation processes that would offer effective advantages in reality and we continually work on improving these processes to suit best to our requirement as we work mostly on the latest generation of anti-cancer drug products where the APIs (drug substances) are quite precious as they are obtained after several steps of synthesis.

Our aim is to have a proper design of experiment (DOE) that would help us develop an efficient granulation with minimal efforts and would afford a linear scale-up with minimal changes in process parameters and with effective usage of equipments.

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FURTHER DEVELOPMENTS

Less amounts of API handling for optimization of granulation process

Automation of granulation for any scale

Minimizing risk factors with respect to drug substance

In-line analytics for real time monitoring of critical process parameters

Disclaimer

Some services are still being built up and ready only by Y2024. Please inquire for further information and updates through