Professional Documents
Culture Documents
By
I acknowledge the School of Pharmacy, University of Auckland, New Zealand, who has served
as a great resource in this book Publication .
Pharm.Osemenam Henry
(H.O.D Pharmacy Technican Department)
Chapter One
The pharmacopoeias (B.P,U.S.P)are the main source of dose information and generally give
the dose ranges within which agents are generally therapeutically useful for the average patient.
The dose may have to be modified according to the factors mentioned above. In the General
Notices of the British Pharmacopoeia (1980), the section entitled “Doses” states;
“The statements given under “Usual dose range” in the Monographs of the Pharmacopoeia are
primarily
intended for the pharmacist; they are not authoritatively enjoined as binding upon prescribers.
They are
intended for general guidance and represent, unless otherwise stated, the usual range of
quantities which
are usually regarded as suitable for adults when administered by mouth on one occasion. For
some
substances a period is stated over which the whole dose is given, e.g. “daily in divided doses”,
the division
being left to the prescriber. If it is usual to administer a drug by a method other than by mouth,
the dose
suitable for that method of administration is stated.
It must not be assumed that the dose indicates the greatest amount of drugs that may be given.
The
medical practitioner will exercise their own judgment and act on their own responsibility in
respect of the
amount of any therapeutic agent they may prescribe or administer, or the frequency of its
administration.
When, however, an unusually large dose appears to have been prescribed, it is the
responsibility of the
pharmacist to satisfy himself that the prescriber’s intention has been correctly interpreted.
Following the statements of doses of preparations of some of the more active drugs, notes have
been
placed to show the approximate quantities of active ingredients contained in the doses stated.
These are
included for the guidance of the prescriber and are not to be regarded as statements of
standard.”
For large numbers of drugs and preparations the BP provides at the end of the monograph a
statement of
“Actions and Uses” and (if applicable) “Usual Dose”.
A typical example is:
Aspirin
Actions and uses - Analgesic antipyretic
Usual Dose Range - 0.3 g to 1g; up to 4g daily, in divided doses. In the treatment of acute
rheumatism 4g
to 8g daily, in divided doses.
The Pharmacopoeia attitude to dose is very formal. A better appreciation of practical dosage
schedules can often be obtained from APF, BNF, Martindale or the Pharmaceutical Codex.
Manufacturers’ literature and compendia such as the New Ethicals Compendium provide also
useful sources of information about dosage.
3. Minimum dose
The lowest dose exerting the desired therapeutic effect in the average patient.The response of
the patient will indicate whether in continuing treatment this dose should be maintained or
increased.
4. Maximum dose
The highest dose usually tolerated without undesirable effects in the average patient. This dose
is not the greatest amount that can be administered, as in certain specific treatments the official
maximum dose may be exceeded.
5. Toxic dose
The dose capable of producing marked functional derangement in the body.
6. Lethal dose
The smallest dose known to have produced a human death.
7. Prophylactic dose
The dose necessary to prevent the onset of a disease.
8. Therapeutic dose
The dose necessary to treat an established disease.
9. Loading dose
A dose higher than the maintenance, given on the initiation of therapy to give rapid drug plasma
levels equivalent to that reached after multiple dosing. This higher dosage is used for a short
period of time only; often it only involves a single dose.
10. Maintenance dose
A dose given to maintain the therapeutic level of a drug in the body.
No patient should leave the pharmacy without knowing HOW to use the medicine, how
MUCH and how OFTEN. At all times the written instructions should be primarily regarded
as back-up to the pharmacist’s/pharmacy Technicians oral counseling.
When producing a label, you should ensure that the information on the label is:
1. In a language appropriate to the patient’s needs. (KEEP IT SIMPLE)
2. Indelible and legible. (KEEP IT CLEAR)
3. The size and type of lettering appropriate to the patient’s needs.
4. of a uniform color contrasting strongly with a uniform background. Directions such as “Not to
be taken “and “For External Use Only” may be in red lettering.
5. Not in the address panel or any other place where it could obstruct or be hidden by other
information.
6. Placed on the label in lines parallel to the base of the container.
7. Placed on the primary container – this is the container that the patient will be using not the
box that they will throw away.
8. Free of errors and overtypes. (KEEP IT CLEAN)
9. Free of unnecessary decoration and embellishment. (KEEP IT PLAIN)
1.6.Record quantity dispensed on label
This is a requirement for:
1. All solid dose preparations.
2. All liquid preparations when the quantity specified does not fill the bottle.
It is however, strongly recommended that the quantity be stated on each preparation.
1.7.The name or description of the nature of the contents
This is legally required and should give the name or the official abbreviation of the name of the
medicine as stated in the prescription, unless:
1. The contents are extemporaneously prepared and contain more than a single active
ingredient. In this
case the batch number and expiry date should also be on the container.
2. The medical practitioner has stated;
a. NNP or Not NP (non nomen proprium)
b. He/she wants some other designation.
Note:
1. If a preparation comes in more than one strength, the label should give the strength supplied
(it is preferred that the strength is always stated on the label).
2. Extemporaneously compounded preparations containing more than one active ingredient do
not need to be labeled with a precise name. If the prescription calls for an official preparation
e.g. BNF, BPC, BP, APF – use their short title on the label to identify them – e.g. Potassium
Citrate Mixture APF.
1.8.Directions for use
It is legally required to give:
1. Dose, and frequency of dose (Internal preparations)
Please note that you need to word the directions according to the formulation of the product.
For example: ‘Take one tablet’
‘Dissolve the contents of one sachet in water and
‘Insert the contents of on applicatorful..’
2. Method and frequency of use/application (external preparations)
3. Special individual directions as per the prescription form.
Please note that the directions on the label should exactly reflect the prescription.
There is no need for additional information (e.g. take for pain relief) unless it is specified
in references such as C& A labels from the Dispensing Guide.
Some useful things to note when preparing labels for medicines:
1. A prescription with non-specific directions, such as “use as directed” (mdu) or when required
(prn), the pharmacists must ensure the patient understands the directions clearly and correctly,
and where necessary provides written guidance. The pharmacist may have to find out from the
prescriber the exact medication instructions. It is advisable to know the normal dosing
regimen before contacting the prescriber.
2. The nature of the contents may be such that ancillary labeling is required. Think of what the
additional label is saying and position it to do its job – e.g. if the preparation is to be shaken
before pouring the dose,put “Shake the bottle” above the main label. If ancillary labels need to
be attached, place them horizontally, and avoid placing them on the main label or obscuring any
writing on the label. If you choose to put some of these on the medicine label using the
computer, make sure that the font is large enough to be read clearly by the patient.
3. Once the practitioner does not wish a CAL to be attached, he/she must endorse the
prescription “NCL”. The use of CALs is not a legal requirement. Use your professional judgment
in their application.
4. Keep the wording simple and specific:
Tell the patient what to do with the medicine (e.g. Take two tablets), how often (e.g. four
times a day) and then additional information (e.g. after food).
Example:
“Take” rather than “to be taken”
“Do not swallow” rather than “Not to be taken”
“Spread thinly” rather than “Use sparingly”
“Put TWO drops into” rather than “Instil TWO drops”
“Place a patch”…….. (transdermal patches)
“Inhale TWO puffs TWICE a day” (inhalers)
Try to avoid having the number to be taken and the times of taking adjacent:
Example:
“Take TWO tablets FOUR times a day” rather than “Take TWO 4 times a day”
“Take TWO tablets TWICE a day” rather than “Take TWO TWICE a day”
Fractions should be expressed in words rather than in figures.
Example:
TWO AND A HALF ML rather than 2.5 mL
or both words and figures i.e. TWO and a HALF ml (2.5ml)
Distinguish between different drug delivery forms:
Example:
“Swallow whole” Sustained release preparations
“Dissolve under the tongue” Sublingual tablets
“Chew” Chewable tablets
5. “Give” is preferred when the dose is prescribed for a young child or an animal
Example:
“Give ONE 5mL spoonful THREE times a day.”
1.9. Measures: Only metric measures may be used, imperial must not be used.
(a). Weights: g is the official abbreviation for gram
mg is the official abbreviation for milligram
mcg is preferred to ug microgram
It is recommended that to avoid confusion, micrograms are written out in full.
(B). Volume: ml or mL preferred abbreviation for millilitre
L preferred abbreviation for litre
7. Remember to provide with the medicine, where appropriate, a measuring device for the
patient for example a 5mL medicine spoon or an oral syringe.
6. Where appropriate, reference should be made to appropriate patient information leaflet for
instructions on how the product should be used.
1.9.1.Reference Number
The prescription reference number generated by the computer is a legal requirement. In
dispensing labs, unique identifier will be used for each product dispensed.
1.9.2..Date of dispensing
The date of dispensing is a legal requirement and that the format is 21 Feb 01 rather than
21/02/01, to avoid confusion with reference numbers.
1.9.3.Patient’s Name
This is a legal requirement. It is preferred that the title, initial(s) or first name and surname be
shown. On an animal’s medication, the owner’s name must appear on the label. The statement
“Not for Human Use” or “For Animal Treatment Only” must appear on the label.
1.9.4..Name and Address of the Pharmacy
These are legal requirements. The name of the proprietor or the registered trade name of the
company and the address of the pharmacy (not a P.O. Box number) must appear on the label.
The telephone number is an ethical requirement.
1.9.5.Prescriber’s Name or Reference
Optional, but advisable, and preferred
Place the label so that it is:
1. Easy to read, with no blemishes.
2. Firmly fixed to the container (which is clean).
3. Straight and visually balanced.
4. Not likely to be damaged, defaced or removed when the container is opened.
5. Not obscured by another label, folder, pamphlet etc.
6. On both the inner and outer container if both are being supplied (always label the primary
container).
Please note – there is a new Labelling policy for dispensing labs and this should be
followed closely. You
will find this in Appendix A at the end of this manual
1.9.7.EXPIRY DATES
There is no collaboration between established formularies and textbooks concerning expiry
dates assigned to extemporaneous preparations. Stability data is unavailable on many
formulations. In many cases you must make a professional judgment on the most appropriate
expiry date for a product.
For the purposes of Dispensing classes the following guidelines should be observed:
1. Freshly prepared
As a guide to good pharmaceutical practice it is suggested that mixtures or other medicines
recommended to be
“freshly prepared” should be prepared not more than 24hrs before issue to a patient.
2. Recently prepared
Mixtures recommended to be “recently prepared” should be stored in full, air tight, unopened
bottles in the pharmacy for not more than 3 months.
Stock mixtures in use, in opened containers in the pharmacy, should be used within 2 weeks of
first opening.
1.9.8..Recommended Expiry Dates for Dispensing classes
Unless otherwise stated in the formula the following guidelines should be observed.
Internal Preparations without a preservative 7 days
Internal Preparations with a preservative 14 days
1.9.9External Preparations
However, pharmacists may feel that there are a number of other drugs and preparations which
should have such
closures, and may consider adding a small charge to the patient. For example, all external fluids
should have CRCs, if approved by the patient, or forfeit the extra charge; if it is the policy of that
pharmacy to supply such closures.
Product
Labelling
Attendance
Neatness
Dressing
Group work
Total
Practical
Product
Labelling
Attendance
Neatness
Dressing
Group work
Total
Egg Race
Runnung
Football
Contest
Payment
Dressing
Sack Race
3rd Year 1st semester
Practical
Product
Labelling
Attendance
Neatness
Dressing
Group work
Total
3rd Year 2nd Semester
Practical
Product
Labelling
Attendance
Neatness
Dressing
Group work
Total
Egg Race
Runnung
Football
Contest
Payment
Dressing
Sack race
CHAPTER 2
This section will include Solid preparation intended for both external and internal
use.The following types of preparation will be considered.
In addition powders for internal use are majorly non-potent medicaments such as
certain antacids,kaolin etc.
2.1.Preparation of 100g of zinc Starch and Talc dusting powder
Product directions
For external Use only
Store in a dry place
Not to be applied to open wounds or raw weeping Surfaces
Do not Use after (3months)
Patient Name Date of dispensing
Calculation: The instructor tells you the amount to send/rescalling the Product formulae
1000g 100g
1.weigh The required amount of zinc Oxide BP using a Class II or Electronic Balance
5.Add zinc Oxide BP to the starch BP in the mortar and mix Using a pestle
NOTE: The powder are admixed in order of volume ,remembering the ‘doubling-up’
technique
6.Add thePuriified Talc BP to the powders in the Mortar and continuing mixing
7.Transfer the mixed powder to a ‘Powder shaker’ container or an amber glass jar
LABELLING
Product directions
Calculation: The instructor tells you the amount to send/rescalling the Product formulae
1000g 100g
Method:
6.Transfer the mixed powder to a ‘Powder shaker’ container or an amber glass jar
LABELLING
3.Considering the principle of ‘doubling up’ List the order of addition and
justify your reasons .
Answers:
2.3.Preparation of Compound Sodium chloride and dextrose Powder
Product directions
Calculation: The instructor tells you the amount to send/rescalling the Product formulae
Ingredients Quantities
Dextrose BP 20g
Use:Each powder is dissolved in 500ml of recently boiled and cooled water to make a
solution.
Method:
6.Transfer the mixed powder to a ‘Powder shaker’ container or an amber glass jar
LABELLING
3.Considering the principle of ‘doubling up’ List the order of addition and
justify your reasons .
Answers:
2.4.Preparation of Aromatic Water and diluton
Aromatic water involves water used for flavouring.They add a pleasant smell to
preparations.They sometimes serve double functions ,as flavours and as vechilcles in
Preparations.They are used to mask some bitter taste e.g Menthol and peppermint oil
have a slighthly aneasthetic action and therefore cause numbness on the taste buds.
The concentration of aromatic water are normally determined by the extent of Aroma.
Dilution of concentrations is necessary to get acquaintance with because most of this
aromatic waters are sold or stored in the concentrated form;dilution are done to give the
required strength / amount.
a.calculation
b.Procedure
c.Labelling
d.Uses
Exercise 3.0:Preparation of 150ml of Alkaline Gentian Mixture BP
Product directions
Portable water to
Portable Water to
1000ml
(BPC 1959)
Method
1.using the rmaster formulae from the British pharmacopoeia for 1000ml of final
product,calculate the quantity of ingredients required to produce final volume needed
(150ml)
5. the sodium bicarbonate BP (7.5g)should be added to the vechicle ,thus following the
principle of adding solutes to solvents
8.rinse the beaker with portable water,adding the rinsings to the sodium bicarbonate BP
solution
11.Transfer the solution to a 150ml amber flat medicine bottle with a child resistant
closure and label
Labelling
Answers:
Exercise 3.1. Preparation of 50mL of Ammonium Chloride Mixture BP
Product directions.
Method
1.Calculate the quantity of ingredients requires to produce the final volume needed.
4.add the Ammonium chloride BP to the water in the beaker and stir until dissolved .
6.Measure 5ml Liquorice Extract BP accurately in a 5mL conical measure and add with
rinsings to the 50mL measure containing ammonium Chloride Solution.
7.Measure 2.5mL Aromatic Ammonia Solution BP accurately in a syringe and transfer to
the 50mL measure containing the composite solution.
8.Make up to the final volume of 50mL with portable water and stir.
Labell
Answers:
Exercise 3.2.Preparation of 150mL of Sodium Chloride Compound Mouthwash BP
Product directions
Not to be Taken
Method
1.Using the master formula from the british Pharmacopoiea for 1000mL of final
Product ,calculate the quantity of Ingredients required to produce the final volume
needed(150ml)
2.Calculate the composition of a convenient quantity of double strenghth chloroform
Water BP ,sufficient to satisfy the formula requirements but also enabling
simple,accurate measurement of the concentrated component.
7.When the Sodium Bicarbonate BP has dissolved, add the sodium chloride BP and
stir to aid dissolution.
9.Rinse out the beaker with some Double Strenght Chloroform Water BP and add the
risings to the conical measure.
12.Make up to volume with the remaining double Strength Chloroform Water BP and
portable Water
LABELLING:
Questions: 1.What type of Solution was produced and its intended use
Answers:
Exercise 3.3.Preparation of a Magistral formulation (150mL of Pottassium
Permaganate solutions 0.2%w/v)from a doctors prescription
Product Directions
Method
4.Rinse the mortar with freshly boiled and cooled purified water;add the rinsings to the
conical measure.
6.Transfer the solution to a 150mL amber fluted medicine bottle with a child-resistant
closure and Label
LABELLING
Questions: 1.What type of Solution was produced and its intended use
2.what is the function of using freshly boiled purified and cooled water in this
preparation
Answers:
Exercise 3.6.Preparation of Paracetamol Elixir Paediatric (Elixir)BPC 1973 page
674)
Ingredients Quantities
Paracetamol BP 24g
Glycerol BP to 1000mL
LABELLING
CALCULATION
METHOD
Ingredients Quantities
Syrup BP to 1000mL
This product would be recently prepared and therefore would attract a four week discard
date.
LABELLING
CALCULATION
METHOD
Intended Use
Chapter 3
Preparation of Emulsions
Emulsions is essentially a liquid preparation containing a mixture of oil and water that is
rendered homogenously by the addition of an emulsifying agent. The emulsifying agent
ensures that the oil phase is dispersed throughout the water as minutes globules. In
practice a gum is used to make an emulsion .This can be done through the wet and dry
gum method.
Product Directions
Acacia BP 0.75g
Acacia BP qs qs
4: 2 1
In this case 60mL of coldliver oil BP is required ,therefore 4parts=60mL.One part will
therefore be 60/4=15.Therefore,the amount of freshly boiled and cooled purified water
needed is 2 x 15 mL=30mL.The amount of acacia required =15g
Therefore the product formula for 200mL of cod liver Oil 30% emulsion is ;
200mL
Acacia BP 15g
Method
Labelling
Questions: 1.What type of preparation was produced and its intended use
2.what is the function of double strength Chloroform water ,Acacia gum , Acacia oil in
this preparation
Answers:
a.Formula
b.Method
c.Labelling
d.intended Use
Arachis oil 40% v/v emulsion 150mL
Product directions
Acacia BP 1.5g
Formula:
Method:
Labelling
Intended use
Questions
2.what is the function of double strength Chloroform water ,Acacia gum , Acacia oil in
this preparation
Answers:
Exercise 4.2:Preparation of Magistral formulation of 200mL of Liquid paraffin BP
15% emulsion from a doctors prescription
a.Formula
b,Method
c..Labelling
d.intended Use
Liquid paraffin 15% v/v emulsion 200mL
Product directions
Acacia BP 15g
Formula:
Method:
Labelling
Intended use
Questions
2.what is the function of double strength Chloroform water ,Acacia gum , Acacia oil in
this preparation
Answers:
Exercise 4.3:Preparation of 100mL of Liquid paraffin Emulsion BP
a.Formula
b,Method
c..Labelling
d.intended Use
Liquid paraffin Emulsion BP 100mL
Product directions
1000mL 100mL
Methylcellulose BP 20g 2g
Intended use
Questions
Answers:
Exercise 4.4:Preparation of 200mL of White Linment BP
a.Formula
b,Method
c..Labelling
d.intended Use
White Linment BP 200mL
Product directions
Intended use
Questions
a.Formula
b,Method
c..Labelling
d.intended Use
Salicyclic Acid and Sulphur cream BP 20g
Product directions
Intended use
Questions
Answers:
Exercise 4.5:Preparation of 20g of compound aluminum Paste BPC 1973,page
767
a.Formula
b,Method
c..Labelling
d.intended Use
Formula:
Intended use
Questions
2.what is the function of aluminium,zinc oxide and liquid paraffin in this preparation
Answers:
Exercise 4.4:Preparation of 20g of Salicyclic Acid and sulphur cream BP
a.Formula
b,Method
c..Labelling
d.intended Use
Salicyclic Acid and Sulphur cream BP 20g
Product directions
Intended use
Questions
Answers:
Exercise 4.6: A typical Tragacanth gel formula
a.Formula
b,Method
c..Labelling
d.intended Use
Formula:
Tragacanth BP 3%w/w
Glycerol BP 20%w/w
Alchol BP 2.5%w/w
Methylparahydroxylbenzoate BP 0.2%w/w
Water to 100%
Method:
Labelling
Intended use
Questions
Answers:
Exercise 4.4:Preparation of 20g of Salicyclic Acid and sulphur cream BP
a.Formula
b,Method
c..Labelling
d.intended Use
Salicyclic Acid and Sulphur cream BP 20g
Product directions
Intended use
Questions
Answers:
Exercise 4.6:Preparation of 30g of simple ointment BP
a.Formula
b,Method
c..Labelling
d.intended Use
Product directions
1000g
Intended use
Questions
2.what is the function of aluminium,zinc oxide and liquid paraffin in this preparation
Answers:
Exercise 4.4:Preparation of 20g of Salicyclic Acid and sulphur cream BP
a.Formula
b,Method
c..Labelling
d.intended Use
Salicyclic Acid and Sulphur cream BP 20g
Product directions
Intended use
Questions
Answers:
Exercise 4.6:Preparation of calamine Lotion (BP 1988,pg 702)
a.Formula
b,Method
c..Labelling
d.intended Use
Formula:
Calamine BP 150g
Betonite BP 30g
Sodium Citrate BP 5g
Glycerine BP 50mL
Intended use
Questions
Answers:
Exercise 4.7:Preparation of salicyclic Lotion (BP 1988,pg 702)
a.Formula
b,Method
c..Labelling
d.intended Use
Formula:
Intended use
Questions
2.what is the function of Salicyclic acid,castor oil and alchol 95%BP in this preparation
Answers:
References