Preparation of semisolid dosage forms on a laboratory or compounding pharmacy scale can be accomplished using one or more of the following techniques and principles:
Manufacturing
processes
Preparation
of semisolid dosage forms on a laboratory or compounding pharmacy scale can be
accomplished using one or more of the following techniques and principles:
·
Geometric mixing using a spatula on a plate. This allows
uniform incorporation of a small quantity of an ingredient into a large
quan-tity of the other ingredient(s). Geometric mixing involves mixing a small
quantity ingredient with the same volumetric or weight quantity of the larger
quantity ingredient, followed by repeating this procedure with the small
component mix until all the large quantity ingredient has been incorporated.
·
Powder communition or particle size reduction by grinding in
a pestle and mortar.
·
Levigation by grinding the powder in a small quantity of
suitable levi-gation aid in a pestle and mortar, followed by geometric mixing
with the base using a spatula on a plate.
·
Fusion by melting the components together on a water bath.
·
Using pestle and mortar to prepare an emulsion concentrate
using lower quantity of the external or continuous phase, followed by dilu-tion
of the emulsion concentrate to volume.
Manufacture
of semisolid dosage forms on a large scale presents challenges with respect to
the inherent viscosity of the formulation, non-Newtonian flow characteristics,
possibility of air entrapment, heat distribution within a vessel, variation in
the volume of liquid components with changes in oper-ating or ambient
temperature, and the energy requirement for efficient mix-ing of viscous
fluids.
On
a pilot plant to a production scale, semisolid formulations are manu-factured
using one or more of the following equipment and techniques:
1.
Electrically operated propeller mixer in a suitable mixing
vessel.
2.
Temperature control using jacketed mixing vessel, with the
jacket having a supply of hot or cold water or steam. The mixing vessel also
often has a mixer that sweeps close to the wall to prevent overheating and
allow mixing of semisolid mass, which otherwise has low convec-tive mixing
rate.
3.
Homogenization using a homogenizer mixer or a colloid mill.
4.
Use of proportioning pump to allow simultaneous blending of
phases.
5.
Transfer of the semisolid material from one unit operation
to another, or to the packaging line, in a container, gravity-facilitated, if
feasible, or pumping through a tube.
The
choice of technique depends on rheological properties of the formula-tion in
addition to plant design and feasibility of equipment.
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