Compounding

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‫فتداووا‬

‫َ‬ ‫* قال رسول الله‪( :‬ما من داء إال أنزل الله به دواء ‪،‬‬

‫بالمحرم )‬
‫ّ‬ ‫تداووا‬
‫وال َ‬

‫* حديث صحيح‪.‬‬

‫‪Sarah Al-Gethami‬‬ ‫‪1‬‬ ‫‪12/08/2021‬‬


* Extemporaneous
Preparations in
Hospital Pharmacy.
.By: Sarah Al-Gethami
.Pharm D. candidate

Sarah Al-Gethami 2 12/08/2021


*Outlines
* Definition.
* Regulation.
* Requirements.
* General notes on common orders:
* Syrups.
* Suspensions.
* Capsules.
* Molded tablets.
* Topical preparations.

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*Definition:
*Preparation, mixing,
assembling, packaging and
labeling of drug product
based on a prescription order
from a licensed practitioner
for the individual patient.
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*Why compounding?
* When a pharmacist can combine several
medications the patient is taking to increase
compliance.

* When the patient is allergic to certain


preservatives, dyes or binders in off-the shelf
medications.

* When medications require flavor additives to make


them more acceptable. for some patients, most
often children

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*Regulations:
* Current good manufacturing practices:
These guidelines specify the minimum standards
required in order to maintain the quality of the
product and ensure the safety of the patient.

* Legal consideration:
As the pharmacist must assure that the correct
drug, dose, patient counseling and directions are
provided.

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*Requirements for compounding:

a- Sources for chemicals and drugs.

b- Equipment.

c- Location.

d- Sources of information.

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a- Sources for chemicals & drugs.

*Pharmacists must obtain small quantities of the


appropriate chemicals and drugs from
wholesalers.

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b- Equipment.

1- Weighing
equipment.

2-Measuring 3-Compounding
equipment. equipment

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1- Weighing equipment:

*An accurate balance


(electronic or beam).

*Weighing and filter paper.

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2- Measuring equipment:

*Glass measures (10ml, 25ml,


50ml, 100ml, and 250ml).

*Micropipettes for volumes less


than 1ml.
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3- Compounding equipment:
*Mortars and pestles :
1. Glass mortar: are preferred for trituration of

substances that stain.


2. Wedgwood mortar: dyes must never be triturated
in a Wedgewood mortar as the color will become
permanently fixed to the mortar & threaten future
powders.

3. Porcelain mortar: are useful in making emulsions


or solutions not involving staining substances.
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3- Compounding equipment:

* Ointment slab and spatulas.

* Stirring rod (glass).

* Funnels of various sizes.

* Heating facility (gas or electric) &


thermometer.

* Tablet molds.
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c- Location:
* The area should be away from heavy foot
traffic.

* Should be near a sink.

* There should be enough space to work


and store all chemicals and equipment.

* It should have adequate lighting and


ventilation.

* It should be free of infestation by insects,


rodents, and other vermin.

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d- Sources of information:
* Library at college of pharmacy.
* Text books:
o Remington’s pharmaceutical
sciences.
o Merck Manual.
o U.S/U.K pharmacopeia and
national formulary
* Journals (Hospital Pharmacy,
Pharmacy Times, U.S Pharmacist)
* Manufacture’s drug product
information inserts.
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*Common orders:

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a- Syrups:

*Definition:
A syrup is a sweet, concentrated, aqueous
solution of a sugar in water.

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*About syrups:
* It is important for syrups to be
“nearly saturated”.

* The sugar most commonly used is


sucrose, common table sugar, though

other sugars can be used.

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*Preservation of syrups:
i. Temperature: Syrups should not be stored
above 25º C.
ii. Glycerin: 30% glycerin may be effective in
preserving some syrup.
iii.Additives: Methylparaben (0.05-0.25 %),
benzoic acid, or sodium benzoate.

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*Suspensions:
*Definition:
Are liquid preparations
that consist of solid
particles dispersed
throughout a liquid phase
in which the particles are
not soluble.

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*General character of
suspensions:

* All suspensions contain an antimicrobial preservative.

* The solid particles will settle in the liquid unless a


suspending agent is added.

* Tight containers are necessary for the stability of the final


product.
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*Notes while compounding:
o Insoluble powders should be reduced in size
to decrease settling.
o A thickening agent must be used to increase
the viscosity and keep the particles
suspended e.g. Methylcellulose or
Tragacanth.
o Oral suspensions should have pleasant taste
and odor.
o Suspensions are never filtered.22
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c- Capsules:
*Definition:
They are a solid dosage form in which the drug is
enclosed in a hard or soft gelatin shell.

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*Capsule sizes:

*Smallest size: No.5 (60-130mg)

*Largest size: No.000 (650-2000mg)

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*Compounding of capsules:
*The solid drug is reduced in size and then the body
of the capsule is filled with the powder using a

capsule filling device.

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d- Molded tablets:
* They are created by moistening the powder mixture with
alcohol and water. They are used for compounding potent

drugs in small doses.

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* Special notes on compounding:
* Molded tablets are made in special molds made
out of a pegboard & a corresponding perforated

plate.

* A diluent & a moistening agent are required.

* The diluent is triturated with the active


ingredients.

* A paste is made using the moistening agents.


12/08/2021
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*Topical preparations:
*Creams.

*Ointments.

*Gels.

*Pastes.
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*Creams:
* Emulsion of water and oil classified as oil in
water (o/w) or water in oil (w/o).

* It normally contains less than 50% of


hydrocarbons.

* Spread easily & do not leave the skin greasy


& sticky.

* Creams contain emulsifiers and


preservatives which may cause contact
allergy.

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*Ointments:
* Provides a protective film on the skin.
* Contain more than 50% of hydrocarbons.
* Contains no water & does not require a
preservative.

* Occlusive effect enhances penetration of


active drug and improves efficacy.

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*Gels:
* Transparent preparations containing
cellulose ethers in water or a water-

alcohol mixture.

* Gels tend to be drying.

* They are useful in hairy areas.

* They are cosmetically acceptable.

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*Pastes:
* Mixture of powder & ointment (e.g., zinc oxide
20% paste)

* Addition of powder improves porosity


* Addition of powder to change an ointment into
a paste also increases the consistency of the
preparation so that it is more difficult to rub
off.

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* General notes on compounding topical
preparations:
* Mixing can be done in a mortar or on an ointment
slab.

* Liquids are incorporated by adding them to the


base by levigation.

* Insoluble powders are reduced to a fine powder &


then added to the base, using geometric dilution.

* Water soluble substances are dissolved with water


& then incorporated with the base.

* The final product should be smooth & free of any


abrasive particles.
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*References:
* Comprehensive pharmacy review, 2nd edition.
* Health Science Academy Pharmacist’s Assistant Training
Programme, Post basic level, Module 3 resource Guide –
Manufacturing and compounding.

* Medical department center and school Fort sam houston,


texas.

* Manufacturing and Compounding of Medications, Saudi


food & drug authority.

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Thank you

Sarah Al-Gethami 36 12/08/2021

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