Compounding

Irene Brinkmann
Pharmacy Practice & Policy
 Learning Objectives
Define what compounding is
Describe the role of compounding in a patient-care setting
Describe the limits of a compounding pharmacist
Describe the compounding procedure
Describe the requirements of a compounding environment
Express drug concentrations in different strengths (w/w, w/v, v/v)
Calculate drug doses and rates of infusion
 Compounding
• Compounding: Combining or mixing together two more ingredients (of
which at least one should be an API) to create a final product in an
appropriate dosage form
• Tailored to the needs of a specific patient
• Compounding provides therapeutics alternatives for patients with
unique medical needs that cannot be met by existing drugs/formulations
• Creates alternatives strengths and dosage forms
• Suitable for patients with allergies to existing formulations
• Fills gaps in cases of shortages and discontinuation

• NB!!! Unlike in a pharmaceutical company, compounding procedures

are not standardized or tested for their ability to produce safe and
effective drugs
• Therefore, must distinguish between manufacturing vs. compounding
 The Act - Compounding
•The MRSCA does not provide a definition for compounding
18(5)Subsection (1) does not apply in respect of the sale of a medicine -
(a)compounded by a medical practitioner, a pharmacist, a practitioner, a
registered nurse, a veterinarian, or a para-veterinary professional, in the
course of carrying on his or her professional activities for a particular person
or animal in a quantity not greater than the quantity required for treatment
as determined by the medical practitioner, the pharmacist, the practitioner,
the registered nurse, the veterinarian or the para-veterinary professional; or

(b)compounded by a pharmacist in a quantity not greater than that

prescribed under this Act for sale in the retail trade, subject to the conditions
prescribed, or in a quantity for a particular person or animal as prescribed by
a medical practitioner, a dentist, a practitioner, a veterinarian or a
para-veterinary professional, as the case may be,
 The Act - Manufacturing
• According to the Act, “Manufacture means to carry out operations,
including the purchasing of material, processing, packaging, quality
control, release and storage of medicinal products and related
substances, and “manufacturing” has a corresponding meaning”
• Involves formulating drugs that are commercially available
• Patient is matched to the drug
• Pharmacies are not allowed to manufacture drugs
The Regulation - Compounding
19(1) A pharmacist compounding a medicine for sale
in the retail trade as contemplated in section 18(5)
(b) of the Act may only compound a medicine that is
-
(a) related to a treatment regimen of a particular patient;
and
(b) sufficient to be used by the patient for not more than
30 consecutive days from the date of dispensing.

(2) Any medicine referred to in sub-regulation (1) must be

compounded extemporaneously
 Compounding
• Compounding may involve
• Using existing drugs as a starting point
• Make use of pure substances (API and appropriate excipients)*
• Compounded products may be sterile or non-sterile
• Sterile products require aseptic techniques to ensure preparations are free
from micro-organisms (injectables, implants or ophthalmic preparations)*
• Nonsterile products are primarily used topically or orally (tablets, capsules,
ointments etc.)

Compounding Procedure
The compounding process begins with a prescription created by a prescriber
responding to a patient’s need
The prescriber will choose the
API
Dosage form
Dosage (dose, frequency, route, duration)
Vehicle/excipients

1. Obtain the recipe/formula {published or created in-house by the pharmacist}

2. Write up a compounding worksheet based on the formula {list of ingredients and
amounts}
3. Collect all ingredients and equipment necessary to prepare the product
4. Weigh/measure each ingredient and have the measurements verified by a
colleague
5. Prepare the compound as per the formula
6. Package and label the product in an appropriate container
7. Clean the workstation and equipment used
Compounding Environment
A suitable area for compounding must first be established before
commencing the compounding process:
Separate from all other work areas
Away from heavy traffic flow
Should be large enough to accommodate all the necessary supplies
Adequate lighting and ventilation
Clean and free from any clutter
Free from any object not directly involved in the compounding process
All tools and surface area should be cleaned just before and after
completing the compounding
PPE
The type of clothing worn is dependent on the type of compounding that
will be done (i.e. sterile or non-sterile)
Sterile preparations will require more rigorous interventions to ensure that
the product is not contaminated
Nonetheless, protective clothing should still be worn even when
compounding non-sterile preparations
Personal hygiene (because the preparation is for people who may already
be ill)
Personal protective equipment
Lab coat
Safety glasses
Face mask
Gloves
Restrain long hair
Practice hygiene by washing your hands before, during and after
compounding
Equipment
• Use appropriate tools based on product(s) being compounded
• Weighing: measure semi-solids/solids
• Measuring Cylinders: Liquids
• Read at the bottom of the meniscus
• Select the smallest measure for the desired volume for best accuracy
• Mortar & Pestle: grinding and mixing
• Glass: for small quantities, substances such as dyes and friable materials (e.g.
crystals)
• Porcelain: Larger quantities
• Rotate pestle in both right and left directions to ensure thorough mixing
• Avoid applying undue pressure to prevent impaction of powder
Mixing Techniques
The goal of mixing is to ensure the even distribution of all ingredients
Mixing of liquids: Simple mixing or stirring the degree of which depends
on the viscosities of the liquids
Mixing of solids with liquids: Consider particle size reduction of the
solid to improve the dissolution and uniform distribution throughout
Mixing semi-solids:
 Fusion method: Bases are gently heated until they have just melted
 Remove from heat and still gently until the mixture has cooled
 Rubbing on a slab
 Doubling-up technique
Labelling
NAME OF PREPARATION, STRENGTH, FORM, QUANTITY

INSTRUCTIONS FOR USE

PRECAUTIONS RELATING TO USE OF THE PRODUCT

‘KEEP OUT OF REACH OF CHILDREN’,

FOR EXTERNAL USE (for certain formulations)

PATIENT’S NAME

DATE OF DISPENSING
EXPIRY DATE
BATCH NO.

NAME AND ADDRESS OF PHARMACY

Calculations
Irene Brinkmann
Pharmacy Practice & Policy
Percentage Strength
Percentage weight in weight (w/w)…g/100 g

Percentage weight in volume (w/v)…g/100 mL

Percentage volume in volume (v/v)…mL/100mL
1. How many grams of dextrose are required to prepare 4000ml of a 5% solution?
200g of dextrose

2. How many ml of a 3% solution can be made from 27g of ephedrine sulphate?

900ml

3. How many mg of hydrocortisone should be used in compounding the following

prescription?
Hydrocortisone 1/8%
Hydrophilic Oint. 10g
12.5mg of hydrocortisone
Ratio Strength
Concentrations of weak solutions are frequently expresses in terms of ration
strength
 All percentages are ratios thus ratio strength is just another way of expressing the
percentage strength
1. What is the ratio strength of a solution made by dissolving 5 tablets each
containing 2.25g of sodium chloride in enough water to make 1800ml?
1:160

2. How many milligrams of hexachlorophene should be used in compounding the

following prescription?
Hexachlorophene 1:400
Hydrophilic Oint. Ad. 10g
25mg
Parts per Million & Parts per Billion
The strengths of very diluted solutions are commonly expressed in terms of PPM or
PPB
1. The concentration of a drug additive in an animal feed is 12.5 ppm. How many
mg of the drug should be used in preparing 5.2kg of feed?
65mg
Master Formulas
a) Calculate the quantities of the respective ingredients to be used in
preparing 60 g of final product:
Ingredient Master formula
Zinc oxide 12.5 parts ( ans. 7.5g)
Calamine 15 parts ( ans. 9g)
Hydrous wool fat 25 parts (ans. 15g)
White soft paraffin 47.5 parts (ans. 28.5g)
Dilution Equations
The Dilution Equation:
C1V1 = C2 V2

C1 = Initial concentration

V1 = Initial volume

C2 = Final concentration

V2 = Final volume

a) What concentration is produced when 400 mL of a 2.5% w/v solution

is diluted to 1500 mL?
b) What is the final concentration if 60 mL of a 12% w/v chlorhexidine
solution is diluted to 120 mL with water?
 Alligation
Calculate the amounts of a 2% w/w metronidazole cream and of metronidazole powder
required to produce 150 g of 6% w/w metronidazole cream.

starting conc. (%) target conc. (%) Proportions

Metronidazole powder 100 4 parts
6
2% metronidazole cream 2 94 parts

Therefore, amount of 2% metronidazole cream = 94/98 x 150 g = 143.88 g

And amount of metronidazole powder = 4/98 x 150 g = 6.12 g

b) Promethazine oral syrup is available as 25 mg/5 mL and 50 mg/5 mL. Calculate the
quantities to use to prepare 150 mL of 40 mg/5 mL of the oral syrup
Practice Questions
1) Express 0.1% w/w as a ratio strength (1:1000)
2) Express 12 p.p.m as a ratio as well as a percentage strength (3:25 000)
(0.0012%w/w)
3) How many grams of a drug should be used to prepare 240 mL of a 5%
w/v solution? (12g)
4) If 5 g of iodine is in 250 mL iodine tincture, calculate the percentage
strength of iodine solution (2% w/v)
5) Calculate the amount of drug in 5 mL of cough syrup if 100 mL contains
300 mg of drug (15mg)
Practice Questions
1. Make 30 g from the following Master formula:
Ingredient Master formula
Coal tar solution 3% 3 g (ans. 0.9g)
Zinc oxide 5 g 5 g (ans. 1.5g)
Yellow soft paraffin 92g To 100g

2. What concentration is produced when 400 mL of a 2.5% w/v solution is

diluted to 1500 mL? (ans. 0.67% w/v)
3. What is the final concentration if 60 mL of a 12% w/v chlorhexidine
solution is diluted to 120 mL with water? (ans. 6%w/v)
4. Promethazine oral syrup is available as 25 mg/5 mL and 50 mg/5 mL.
Calculate the quantities to use to prepare 150 mL of 40 mg/5 mL of the
oral syrup (ans. 50mg/5ml = 90ml and 25mg/5ml = 60ml)
Practice Questions
1. A doctor requires an infusion of 1000 mL of 5% dextrose to be
administered over an 8 hour period. Using an IV giving set which delivers
10 drops/ mL, how many drops per minute should be delivered to the
patient? (ans. 21 drops/min)