Good Practice in Compounding

7/28/2019 Good Practice in Compounding

1/53

PHARMACY PRACTICE

MPHA 2501

GOOD PHARMACEUTICALPRACTICE IN COMPOUNDING

AND DISPENSING

NURULUMI AHMAD

1


2/53

2

Learning Outcomes

At the end of the session, students shouldbe able to:

Identify theresourcesneeded in

compounding and dispensing. Know theequipment used and choose the

appropriate equipment to be used in

extemporaneous compounding anddispensing.

Apply the knowledge in practical session.

2


3/53

3

Resources

The resources that are required forgood compounding and dispensingpractice include:

1. Suitable, well-maintainedpremises,2. An adequate supply ofequipment,

3. Well-trainedpersonnel,

4. Strictcontrol procedures,

5. Readily accessibleinformationsources.

3


4/53

4

1. The Premises

The premises from which a pharmaceuticalservice is provided should inspire confidence

in the users of the service.

Cleanand hygienic,well-organized,tidy,accessibleand secure.

Provide suitable environmental conditions for

both personnel and products (medicines,etc.) e.g. controlled temperature,

acceptable noise level for concentration.

4


5/53

5


6/53

6

2. The Equipment

The equipment in the pharmacy should be

suitableandadequatefor the work to beundertaken.

The equipment required includea means of

counting tablets and capsules,a suitable rangeoflabels, working surface of adequate size,sink,refrigerator,suitablebalanceandweights,mortars and pestles,etc.

All equipment must bemaintainedin accurateworking order (calibration!!!) and checked forcleanliness prior to each use. Log books anduser manuals attached if appropriate.

6


7/53

Tablet counting tray

77


8/53

8Pharmaceutics 1: GDP

Tablet Counting

Machine

8


9/53

9

A. Weighing and Measuring

Balance: Electronic Balances

9


10/53

10

Balance: Triple Beam Balances

Learn how to use the balance at:http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202

10
http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202http://www.wisc-online.com/Objects/ViewObject.aspx?ID=GCH202


11/53

Weighing: Balances

Important equipment in pharmaceutical

formulation.

Torsion and electronic balances.

Recognize maximum capacity (including the

weight of tares weighing boat/paper/beaker

used) and sensitivity requirement.

Use balance that is appropriate for a

particular task.

11


12/53

Sensitivity Requirement (SR) and Min.

Weighable Quantity (MWQ) of a Balance

All balances have a point below which they cannotmeasure accurately, e.g. 6 mg for a standardprescription balance.

Fancy electronic balances can measure as little as 10

mg, 1 mg, or even 0.1 mg (100 micrograms). Thenumber below which they cannot measure reliably isusually inversely proportional to the price of thebalance!

This cut off point is called the sensitivity requirement(SR).

The sensitivity requirement will tell two things: theminimum amount of drug that can be weighed on that

balance and the increments of the balance measure.12


13/53

Sensitivity Requirement (SR) and Min.

Weighable Quantity (MWQ) of a Balance

In pharmacy, weighing error of 5% or less isacceptable (some potent drugs require up to98% accuracy in weighing).

Therefore, to keep the error below 5%, theminimum amount of substance that can beweighed using a balance should be 20 timesits SR.

i.e. MWQ = (SR 0.05) or, (SR 20).

Any amount smaller than MWQ should beobtained by aliquot method.

13


14/53

14

B. Volumetric Apparatus

Graduated cylinders, beakers, burettes, pipettes. As general rule, choose graduates with capacity equal or just

exceeding the volume to be measured higher accuracy.

14


15/53

Measuring equipment for small volumes.

Pipettes

Syringe

Micropipette

15


16/53

Meniscus reading technique.

16


17/53

17

C. Mortar and Pestle

Forparticle sizereduction, mixing &

makingemulsions.

Made of porcelain or

glass.

Porous, unglazed interiors

(porcelain) shearing

action for makingemulsion, should not be

used for drugs that stain.

17


18/53

18

D. Pellet Knives

Stainless steel spatulawith wooden or hardplastic handles.

Hard rubber or Teflon-

coated stainless steelspatula.

Flexible rubber spatulasor rubber scrapers.

Used forlevigationandspatulationincompounding ointment.

18


19/53

E. Spatulas

Spatula and micro spatula.

19


20/53

20


21/53

21

F. Glass and Plastic Funnels

Used to transfer

solutions from one

vessel or bottle to

another.

Also used with

filter paper in

filtering solution.

21


22/53

22

G. Ointment Slab

Used as a surface forlevigation and

spatulation in

compounding

ointment. Also be used as a

clean, hard surface for

rolling semisolid

material when makinghand rolled

suppositories or

lozenges.22


23/53

23

H. Glass Stirring Rods

Useful for stirring liquid

preparations. Spatulas are not to be

used as stirring rods.

23


24/53

24

I. Heating Devices

1. Hot Plate Offer fast and direct

sources of heat, but

required careful monitoring

to avoid overheating ofingredients.

Must have a carefully

controlled temperature.

2. Water Bath

For desired temperature at

100oC or less.

24


25/53

25

3. The Personnel

Most defects in manufactured medicinal products

arise through human error or carelessness!!! There should be anadequate numberoftrained

personnel i.e. pharmacists and technicians togetherwith appropriate support staff.

Standards ofpersonal hygiene should be high andappropriate clothing worn.

Personnel with potentially infectious disease or

open wounds should NOT be involved incompounding process.

Eating, drinking and smoking should not bepermitted in any area where medicines are

prepared or supplied. 25


26/53

26

4. Strict Control Procedures

In order to assure the quality of all medicines prepared

or supplied, stringent control procedures arenecessary.

Supervision:

The compounding and dispensing of medicines should

be carried out by a pharmacist or by other suitablepersonnel under the personal supervision of apharmacist.

Packaging and labeling:

Suitable containers should be used. Containers shouldbe labeled immediately after filling.

Storage and expiry date:

Appropriate storage conditions should be maintained

and out-of-date stock safely disposed. 26


27/53

27

4. Strict Control Procedures

Documentation

Good documentation of the procedures

involved in production of pharmaceutical

products is essential. All documents must be clearly written.

Do what you document, document what

you do

27


28/53

28

5. Information Sources

United States Pharmacopoeia (USP) British Pharmacopoeia (BP)

British National Formulary (BNF)

Medical Information Management System(MIMS)

Martindale: The Extra Pharmacopoiea

British Pharmaceutical Codex (BPC)

28


29/53

29


30/53

3030


31/53

31

British Pharmacopoeia (BP) Pharmacopoiea is a book

containing directions for theidentification of samples and the

preparation of compound

medicines,and published by the

authority of a government or amedical or pharmaceutical

society.

The British Pharmacopoeia (BP)

is the authoritative annual

published collection of standards

for UK medicinal substances and

the official source of all UK

pharmaceutical quality

standards. 31


32/53

32

British Pharmacopoeia (BP)

Essential reference for anyone involved inpharmaceutical research, development,manufacture and testing, and plays a vital role inensuring that all medicinal substances on theUK market (and other countries market using the

title BP, e.g. simple syrup BP) meet standards ofsafety,qualityandefficacy.

The BP comprisesmonographs,which set out themandatory standards foractive substances,

excipients andformulated preparations,togetherwith supporting General Notices, Appendices (testmethods, reagents, etc) and Reference Spectra.

32


33/53

33


34/53

34


35/53

35


36/53

36


37/53

37

Other Pharmacopoieas include:

European Pharmacopoeia (EP),

United States Pharmacopoeia (USP), Indian Pharmacopoeia (IP),

International Pharmacopoeia (Ph.Int.)

etc.

British Pharmacopoeia (BP)

37


38/53

38


A very useful and widely used reference.

The British National Formulary (BNF)

contains a wide spectrum of information on

prescribing and pharmacology, among

othersindications, side effects andcosts of

the prescription of all medications available

on the National Health Service.

38


39/53

39


It is used by general practitionersand specialist practitioners, and byother prescribers (such aspharmacists, nurses and

paramedics) to help them selectappropriate treatments for theirpatients; as a general referencebook on the wards by nurses whoadminister medications; and by

patients and others seeking anauthoritative source ofpharmacological advice.

39


40/53

40Pharmaceutics 1: References 40


41/53

41Pharmaceutics 1: References 41


42/53

42Pharmaceutics 1: References

42


43/53


43


44/53


44


45/53


45

M di l I f i M


46/53

46

Medical Information Management

System (MIMS)

MIMS is a pharmaceutical prescribing reference guidecontaining information about all drugs in the UKformulary.

The title is published monthly, being sent gratis to all

UK general practitioners and on a paid basis tosubscribers. An electronic version, eMIMS, is part ofthe Healthcare Republic website.

MIMS also serves as a medical advertising mediumand has been published in various forms since the1960s by unrelated organizations in China, Europe,Hong Kong, India, the Middle East, Ireland, Australia,New Zealand and Malaysia (MIMS Malaysia).

46


47/53

47

MIMS Malaysia contains information (brand

and generic names, indications, dosages,

contraindications, special precautions,adverse reactions, drug interactions,

presentations and packings, and prices)

about drugs available in the Malaysianmarket.

47


48/53

THANK YOU

48


49/53


50/53


51/53

Discussion

Explain why using proper techniques

and weighing ingredients with

accuracy are important whilepreparing special compounds in the

pharmacy.


52/53

QUESTIONS

1. Define compounding.

2. Define dispensing.

3. List factors required for good pharmacy

practice in compounding.

4. List factors required for good pharmacy

practice in dispensing.

52


53/53

QUESTIONS

5. You are the new pharmacist incharge of

the in patient pharmacy department. Your

head of pharmacist asked you to prepare

standard operating procedures forcompounding and dispensing. With relevant

examples, discuss the important points

necessary to produce the document.

53

Date post:	03-Apr-2018
Category:	Documents
Upload:	vickylaw2
View:	220 times
Download:	0 times

Good Practice in Compounding

Documents