This document discusses labeling, storage, stability, and beyond use dates of pharmaceutical dosage forms. It covers the key information that must be included on labels like the drug name, strength, instructions. Proper storage conditions are outlined for different dosage forms to protect stability based on factors like temperature, light, and moisture. The importance of stability is explained to maintain the drug's therapeutic properties over time. The beyond use date is defined as the last date the patient should use the medication by based on stability considerations.

1. Introduction to pharmacy and
pharmaceutic
Labeling, storage and stability of pharmaceutical
dosage form and beyond use date
[DEPARTMENT OF PHARMACY]
By tujar kaso (b pharm)

2. objectives
1. LABELING OF PHARMACEUTICAL DOSAGE FORMS
» define the term lebel
» discuss properties and importance of labeling
» discuss informations on the labels
» dicuss Special instructions for particular type of product
2. STORAGE OF DOSAGE FORMS
» Define meaning of storage
» Discuss need for storage of dosage form
» Discuss storage conditions for storing different dosage
forms
» discuss different containers used for storage

3. 3. STABILITY OF PHARMACEUTICAL DOSAGE FORMS
» Define drug stability
» Discuss factors that influence drug stability in different
dosage forms
4. DISCUSS BEYOND-USE DATE

4. LABELING OF PHARMACEUTICAL DOSAGE
FORMS

5. • Label
label means display of printed information which
is securely affixed to the container and primally
packaging containing the medicine.
label should provide the patient with all
necessary information:
» General labeling requirement
» Cautionary and advisory label
» Special instruction for different type of product.

6. Properties of lebel:
• Information given on label should be:
»Accurate
»Legible
»Intelligible
»Adequate and relevant

7. Importance of label:
• to provide consumers with information on
the label
• to ensure the appropriate and safe use of
approved drug
• To distinguish the product from that of
competitors(establish a brand)
• a legal requirement

8. Information on the label:
• includes the name and address of supplier
and date of supply
• give precise details as the content of the
container:
» Name of the medicine
» Quantity of the container
» the strength of the medicine: represents the amount of
active ingredient in each dosage unit(/tab,/cap,/ml)
» Units: as a whole number unit, example:100mg rather
than 0.1g
» Batch identification and
» dilute product: indicate the degree of dilution.

9. • state the storage conditions and shelf life of
the product
» Temperature
» Humidity
» Light
» Shelf life
• give the patient clear and complete
instruction on ha to take or use the product
– Direction
» Amount of rug to be taken
» Frequency and timing of administrating
» Route of administration

10. Cautionary and advisory labels:
• for external use only:
»Ointment
»Creams
»Dusting powder
• keep out of reach of children
• for animal treatment only

11. Recommended cautionary and advisory
labels:
• drowsiness warnings
• potential interaction with other medicine
• potential interaction with food or drink
• Special method of administration:
» with plenty of water
» Dissolve under the tangue
» swallow whole, not chewed
» dissolve or mix with water before taking

12. Special instructions for particular type of
product:
• pressurized inhalation:
» Shake before using
» Pressurized ontainer
» keep away from heat source
• capsules:
» Swallow whole with drought of water

13. • creams:
» For external use only
» Store in cool place
» Donot freeze
• dusting powders:
» For external use only
» Not to be applied to open wounds or weeping surface
• emulsion:
» shake the bottle

14. • enemas:
» for rectal use only
» Shake before use
• eye drops:
» Avoid contamination in use
» discard 28 days after first opening.
• gargle and mouthwash:
» not to be swallowed in large amount
• gel:
» For external use only

15. • ointment,pastes,paints:
» for external use only
• tablets:
» Dissolve or disperse in water before use
• for chewable tablet:
» Chew before swallowing
• for sustained release/enteric coated tablet:
» do not chew or crush

16. STORAGE OF DOSAGE FORMS

17. DEFINITIONS : -
DOSAGE FORM:
• Completed form of the pharmaceutical preparation
in which prescribed doses of medication are
included. Examples: Tablets, Liniments, Ointments,
Powders ,Lotions etc.
STORAGE:
• It simply means keeping things at a place ,till it is
used ,so as to preserve the same properties.

18. NEED FOR STORAGE OF DOSAGE
FORMS
• If the drug is not properly stored and on exposure to
air, heat, light and microbes results in degradation
,loss of efficacy and even cause toxicity.
• Light can bring about photolytic decomposition due
to exposure to certain wave length of light.
• Air present inside the container may catalyse
oxidative degradation or other chemical changes.
• Moisture effects the stability of moisture sensitive
preparation.

19.  Sterile products are required to maintain sterility
implying exclusion of microbes.
 Certain drugs on exposure to air undergoes auto-
oxidation and emulsified lipids are sensitive to
attack. So proper storage of drugs is required which
are sensitive to air, light, moisture.
 The stability of drug depends on temperature and
pH.
ex:- Ampicillin is stored at low temperatures (2 – 8 c).
Ampicillin in solution is not stable at pH > 7.

20. STORAGE CONDITIONS FOR
STORING DIFFERENT DOSAGE
FORMS
Dosage
form
Drug Storage condition Use
Tablets Paracetamol Store it at room
temperature
Keep away from excess
heat and moisture.
Analgesic,
Anti-pyretic,
Anti- inflammatory
Capsule B-complex Keep in brown
colour/amber colour glass
bottles to protect from light.
Store it room temperature.
vitamin
supplement
syrup codeine Keep it in brown colour
glass bottle to protect from
light. Keep in cool place.
Anti-tussive,
Anti-diarrhoel,
Analgesic.

21. Lotion Calamine Store in well closed
container
protective
Emulsion Liquid paraffin
Porcelis pestis
emulsion.
Store in glass container
and keep in cool place
Store at 2 – 8 c . Should
be 15 – 25 c before use.
laxative.
To decrease
swine fever in
pigs.
Suspension Milk of
msagnesia
Store in a cool in and dark
place and keep in air tight
plastic containers.
Antacid.
Ointment clotrimazole Store in acool and dark
place.keep in plastic
tubes.
Anti-fungal.

22. Cream Extract of
jivanti,manjisth
a (ayurvedic)
Store in cool and dark
place. Keep in plastic
tubes.
Healing and
soothing of
wounds.
Parenterals Ampicillin Vials should be stored
at 2 – 8 c for 3 weeks.
For long storage they
should be stored at
-20 c for 4 – 6 months.
Anti-biotic
Opthalamic Tetrazoline Hcl Store in low
temperature and keep
them in amber colour
glass bottles.
used when
irritation and
redness caused
by cold
Powders clotrimazole Store in cool and dark
place in a plastic
container.
Anti-fungal
Gel aloe Store in cool and dark
place away from direct
sunlight

23. DIFFERENT CONTAINERS USED FOR
STORAGE
1. WELL CLOSED:-It protects the container from
contamination with extraneous solids under
normal conditions of storage, handling, transport &
prevent unintentional release of the contents.
2. AIR TIGHT :-It gives protection against extraneous
solids, liquids, vapours under normal conditions of
storage, handling, transport. It prevents changes
due to efflorescence, deliquescence, &
evaporation.

24. 3.SECURELY CLOSED:- This is a air tight container
with a means of preventing unintentional
displacement of the closure.
4.HERMETICALLY CLOSED:-It is impervious to air
and other gases under normal conditions of
storage, handling & transport. Ex:- Glass
ampoule sealed by fusion.

25. Liquid oral preparations
a) Intended to be swallowed (elixirs ,emulsions)
-Glass bottles
b) Not intended to be swallowed ( mouth washes , gargles)
- Ribbed oval glass bottles
Semisolid preparations - creams ,jellies ,ointments
-Collapsible metal or plastic tubes
-Glass or plastic pots.
CONTAINERS FOR DIFFERENT
DOSAGE FORMS

26. • Solid unit dose preparations :-
a) Intended to be swallowed or sucked
(Cachets, soft & hard capsules, pills )
b) Intended for use in body cavities
-Glass ,plastics ,aluminium
-plastic ,metal containers
c) powders
1)For oral administration
Bulk powders -Glass & plastic
2) For external use –
Dusting - used in body cavities .
insuffalations -Air tight glass/plastic
container

27. Gaseous dosage forms
(aerosols , inhalations )
- Metals -Tin coated steel
Aluminium
Stainless steel
-Glass -uncoated g lass
coated glass

28. STABILITY OF PHARMACEUTICAL DOSAGE
FORMS

29. Drug stability
• Drug stability means the ability of pharmaceutical
dosage form to maintain the
physical,chemical,therapeutic and microbial
propertis during the time of storage and usage by
patient.

30. Factors influencing drug stability
• in liquid dosage form:
» ph
»Temperature
»Solvent effect
»Oxygen
»Light
»surfactant

31. • in solid dosage form:
»Moisture
»Excipient
»Temperature
»Light and oxygen

32. In liquid dosage form:
• PH:- ph is the most important parameter
which affect the hydrolysis rate of drugs in
liquid formulation.
• the influence of ph on the degradation rate is:
»Specific acid base catalysis
» different ph rate profile obtained using
different buffer

33. • TEMPERATURE:- increase in temperature
usually causes a very pronounced increase in
hydrolysis rate of drug in solution.
• OXYGEN:-molecular oxygen is involved in
many oxidation particularly drug is likely to be
affected by oxidative breakdown.
• LIGHT:-exposure to ultra violate light is the
most usual cause of photodegradation.

34. • photolabile drugs are usually stored in
container which exclude ultraviolet light.
• SURFACTANT:- the presence of surfactant in
micellar form has a modifying effect on the
hydrolysis of drug.

35. IN SOLID DOSAGE FORM:
• MOISTURE:- water soluble drugs present in a solid
dosage form dissolves in any moisture which has
adsorbed on the solid surface.
• EXCEPIENT:- excipient with particularly high water
contents, affects stability by increasing the water
content of the formulation.
• TEMPERATURE:- the effect of temperature change
on the stability of solid dosage forms can be
complicated for many possible reasons:-

36. • the drug or one of the excipient may melt or
change its polymorphic form as temperature is
increased
• the drug or one of the excipient may contain
loosely bound water which is lost at high
temperature.

37. BEYOND USE DATE
• Beyond use date is the date after which a
product shall not be used. The dispenser shall
place on the label of the prescription
container a suitable beyond use date to limit
the patients use of the article based o any
information supplied by the manufacturer.
• the beyond use date shall not be later than
the expiration date on the manufacturer
container.

38. • For all dosage forms in determining beyond
use date the dispenser shall take in to account
in addition to any other relevant factors:
»Nature of the drug
» container in which it was packed
» storage condition
» length of the therapy