Manufacturing process

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Chapter: Pharmaceutical Drugs and Dosage: Dosage forms - Emulsions

Emulsions are manufactured by a high shear-mixing process, such as homogenization.

Manufacturing process

Emulsions are manufactured by a high shear-mixing process, such as homogenization. The two phases of the emulsion are assembled separately, by dissolving and mixing of the ingredients to form appropriate solutions. Then, phases are combined by slow addition of the dispersed phase into the continuous phase with continuous mixing. An optimum amount of mixing shear and time are determined based on the rate of change of the size distri-bution of the dispersed phase with mixing. The resulting emulsion can then be packaged and/or dispensed.

The sequence of addition of formulation ingredients to the emulsion can be critical for the stability of the emulsion. For example, if an o/w emul-sion is desired and the system contains two surfactants with different HLB values, the surfactant with the higher HLB value should be added first.

In addition, volatile ingredients, such as flavors, and thermosensitive ingredients should be added last, after the emulsion has been formed, to minimize loss during processing. The API may be predissolved in one of the phases or added last depending on drug’s solubility, stability, and par-titioning properties.

Self-emulsifying and self-microemulsifying drug delivery systems are manufactured as nonaqueous preconcentrates by simple mixing to dis-solve all ingredients. The resulting formulations can then be packaged in single or multidose containers for distribution. In cases where the SEDDS or the SMEDDS is to be administered as a unit dose without dilution prior to administration, the dosage form can be packaged in a soft gelatin capsule.

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