Home' Australian Pharmacist : Australian Pharmacist April 2016 Contents Australian Pharmacist April 2016 I ©Pharmaceutical Society of Australia Ltd.
CONTINUING PROFESSIONAL DEVELOPMENT
micronised (particle size <6 microgram;
21.8% bio-accessibility) progesterone.
Both the milled and micronised
progesterone were evaluated in a
compounded product containing
LoxOral (a proprietary excipient blend
for capsules for oral administration) and
Methocel E4M (a proprietary excipient
consisting of cellulose polymers to
facilitate slow release of medicines).
Small drug particles (micronisation)
may be prepared by mechanical size
reduction or milling, or by controlled
production processes, which include
spray drying and supercritical
antisolvent processes.8 Properties of
the micronised drug such as shape
and particle size may be affected by
the technique used, and often the
characteristics of the drug particle
produced by mechanical methods
cannot be well controlled. Those
particles produced by the supercritical
antisolvent process have some
advantages. No organic solvents are
used during the process, and the
product is an amorphous, relatively
stable powder with twice the density
of the starting material despite the
appearance of being ‘light and fluffy’.
Formula and methods
A proposed formula and two methods
of preparing progesterone capsules are
shown in Figure 2. One method uses
a mortar and pestle10
and the other
method uses a RAM machine. RAM is
useful for mixing progesterone with
excipients, as progesterone powder
is fluffy. RAM enables progesterone
powder to be prepared in closed
environment, which means less chance
of exposure for the operator compared
with traditional (mortar and pestle)
Packaging, storage and
Compounded products are to be
labelled according to regulatory
and should include
the approved pharmacopoeial name
(where applicable) and the name and
strength of any preservatives used. All
active ingredients and their amounts/
proportions should be included if a
pharmacopoeial formulation is not used.
Ancillary labels should specify storage
conditions, provide an expiry date and
indicate specific usage conditions. Label
23 should be used.
This product has been
compounded by the pharmacist.
Pharmacists are responsible for
ensuring the quality of compounded
products. They should verify that
products are prepared according to
documented procedures and meet
product specifications before release
to the patient. Reviews of processes
and procedures should be conducted
regularly in order to identify areas for
improvement and the resulting actions
should be documented.
SOLUTIONS THROUGH COMPOUNDING
Figure 2. Proposed formula and methods of preparation
Progesterone 100 mg slow-release capsules size #1 (LoxOral) 100
Progesterone USP, PCCA special micronised
Methocel E4M Premium CR (Hypromellose USP)
Base, PCCA LoxOral
Safety when compounding: Precautions should be taken when compounding
progesterone as it can be absorbed through the skin, mucous membranes and lungs. Wear
appropriate laboratory apparel, eye protection and a respirator. Use an appropriate filter
system to reduce the amount of airborne chemical particles in your laboratory. Monitor
to ensure that there is no direct exposure to the compounder. Pregnant women and
compounders with hormone-related cancer should not compound hormone therapy.
Method 1 (mortar and pestle)
1. Using the principles of geometric dilution, mix progesterone, Methocel E4M CR and
LoxOral base together with trituration in mortar and pestle.
2. Once powders are thoroughly mixed, sieve through an 80 mesh sieve.
3. Encapsulate in size #1 capsules.
4. Transfer to a child-resistant, amber prescription bottle and label.
Method 2 (RAM)
1. In an ointment jar, add in the following order, progesterone, Methocel E4M Premium CR
and LoxOral base.
2. Mix in a RAM machine for 2 minutes on medium setting.
3. Once powders are thoroughly mixed, sieve through an 80 mesh sieve.
4. Encapsulate in size #1 capsules.
5. Transfer to a child-resistant, amber prescription bottle and label.
*The amount of API in each capsule is usually expressed as milligrams (mg). Percentage (%) w/w refers to
grams (g)/100 g.
Note: This is a theoretical formula adapted from Davis K.10
“ANCILLARY LABELS SHOULD
SPECIFY STORAGE CONDITIONS,
PROVIDE AN EXPIRY DATE AND
INDICATE SPECIFIC USAGE
Links Archive Australian Pharmacist March 2016 Australian Pharmacist May 2016 Navigation Previous Page Next Page