Role of Retail Pharmacist for Product Stability.ppt

GSPC REFRESHER COURSE- AUGUST 2022 1
Role of Retail Pharmacist for Product Stability
Prof. Vishnu M. Patel
APMC College of Pharmaceutical Education and Research,
Himatnagar, Gujarat, INDIA

• Retail pharmacist is a licensed pharmacist who works
in a retail pharmacy to provide the services to patients
on prescribed and non-prescribed (OTC) medicines.
• Retail pharmacy means any pharmacy where drugs are
compounded, dispensed, stored or sold or where
prescriptions are filled or dispensed to the general
public.
Retail Pharmacist

Retail Pharmacist’ responsibility
3
PRODUCT STABILITY
To Retain medicine’s strength,
quality, and purity when it is
stored according to its labeled
storage conditions till its shelf
life.
COMPOUNDING
The process of providing
information, advice and
assistance to help patients
use their medicines
appropriately
PATIENT COUNCELLING DISPENSING
preparation, mixing, labeling and
packing of medicines as per need of
individual patient.
Giving already available packed
medicines manufactured by
pharmaceutical companies to patient
on evaluation of prescription.

Retail pharmacist’s Responsibility
for drug stability
• Maintain the quality and integrity of
medicines till their shelf life in medical store.
• Maintain recommended storage conditions of
each medicines.
• Get updated with the proper storage conditions
for new drug formulations.
• Give advise to patients about storage condition,
advice patients on the safe use of medicines and
their potential side effects, if drug is not stored
properly. GSPC REFRESHER COURSE- AUGUST 2022 4
Retail Pharmacist

Product/drug Stability
• Product stability means the ability of the
pharmaceutical dosage form to maintain the
physical, chemical, therapeutic and microbial
properties during the time of storage and usage.
• Drug stability affects the safety and efficacy of
the drug product; degradation impurities may
cause a loss of efficacy and generate possible
adverse effects. Therefore, achieving the
chemical and physical stability of drugs is
essential to ensure their quality and safety.
5
GSPC REFRESHER COURSE- AUGUST 2022
Product stability

Product Expiry
In any medicine, 10% drug is degraded, this
medicine is called expired medicine. So after drug
expiry 90% drug is remained in medicine and
upto 10% drug was degraded. This medicine is
not suitable for use.
So ,medicine must have more than 90% of label
claimed potency during its shelf-life.
Any product after opening of primary packaging,
not suitable for potency claim.
6
Product stability

Early Drug expiry
Reasons for early expiration of drug products:
• Storage condition is not proper as per label during shelf-
life.
• Some drugs are more sensitive to light, temp, humidity.
• Incompatible formulation due to chemical reactions like
oxidation, hydrolysis, isomerization, polymerization.
• container and closure are not appropriate to product
stability standards. eg. Leakage, sorption, temper-proof,
air tight, well-closed,
• Opening of packaging makes the product non sterile:
e.g. Multi dose injection, multi dose tablet bottle, eye
drops etc. After opening the package, the product is
more susceptible to atmospheric oxygen and
microorganisms. 7
Product stability

Short expiry dates
Some medicines are given a short expiry date, such as:
• prepared antibiotic mixtures: when the pharmacist
adds water to powdered antibiotic, it changes the
stability of the product, and the pharmacist will give it
an expiry date of 1 or 2 weeks, depending on the
product
• eyedrops: these are usually given an expiry date of 4
weeks after first opening the container, because your
eyes are particularly sensitive to any bacteria that
might get into the eyedrops. Preservatives gets
degraded rapidly after opening the container.
Product stability

9
25% of vaccines go waste due to lack of cold chain
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Published Articles
Most vaccines are heat sensitive and remain
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critical to their efficacy.
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Rybelsus is a glucagon-like peptide (GLP-1) receptor agonist indicated as an
adjunct to diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus.

10
Poor storage lowers quality of TB drugs
Ekatha Ann John | TNN | Mar 7, 2014, 06.24 AM IST
Even though India is the largest supplier of vaccines
globally, producing 62 per cent of the global
demand, the wastage rate is high.
Written by Editorial Team | Updated : May 12, 2022 4:01 PM IST
High Vaccine Wastage In India: Robust Medical
Cold Chain Set Up Needed To Address The Issue
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Indian Express
Drug regulation: 27 medicines sold by top firms ‘fail’
quality tests in seven states
Face charges of false labelling, wrong quantity of ingredients.
• Written by Deepak Patel | New Delhi |
Updated: November 28, 2016 4:30:53 pm
In a major crackdown since March,2016 , then year, the drug
regulators of seven states have alleged that 27 medicines — sold
by 18 major drug companies in India including Abbott India, GSK
India, Sun Pharma, Cipla and Glenmark Pharma — are of
“substandard” quality, citing discolouration, moisture
formation, failing dissolution test and failing disintegration test.
Published Articles

Gujarat’s drug regulator, which claimed Emcure Pharma’s antibiotic
drug Rifampin was substandard in August, said in its report:
“Almost all vials received for analysis show lumps formation of
the contents of the vials.”
Pentids-400: Abbott received information from the Kerala drug
controller in May 2016 about some tablets of Pentids-400 being
discoloured and having moisture. Testing performed for a portion
of the collected samples by a government laboratory confirmed that
the product met all specifications. Control samples and batch
records of the same batch were also found satisfactory, and we
have not received any other complaints from this batch. This
isolated event was caused by inappropriate storage and handling
in the marketplace. We have shared these details with the state
drug authorities, explaining why there was no need to recall the
said batch.
Published Articles

May 11, 2021
Insulin Product Samples Recalled Due to Improper
Storage Temperature Conditions
Novo Nordisk is voluntarily recalling 1468 product samples of
Levemir® (insulin detemir [rDNA origin]), Tresiba® (insulin degludec),
Fiasp® (insulin aspart), Novolog® (insulin aspart [rDNA origin]) and
Xultophy® (insulin degludec) to the consumer level due to the
products being stored at temperatures below storage requirements.
Published Articles
Govt Shuts 34 Medicine Outlets For Non-Compliance
Channels Television
Updated December 10, 2021
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14
Published Articles
Lucknow: Over 2 lakh expired medicines in
Lohia hospital’s store, DyCM Brajesh Pathak
orders probe
TNN / Updated: May 13, 2022, 14:33 IST
Expired drugs seized from medical store in
Patna
VK Tripathi / TNN / Updated: Aug 4, 2021, 13:03 IST

15
Published Articles
Affecting quality: A pharmacy in south Delhi.
(photograph by Rajeev Dabral / MINT)
3 min read . Updated: 11 Aug 2008, 12:24 AM IST C.H. Unnikrishnan
Improper storage at retail stores reduces drug
potency: study
Drugs in India lose 3-4% of their potency at
chemists’ shops because they are not stored
properly, results of a recent study show.

16
Published Articles
Poor storage: Your pharmacy is probably
spoiling medicines
The medicines you consume probably aren’t
working as effectively as they should, because
pharmacies often don’t adhere to the
specified storage conditions.
Published: 29th August 2019 03:45 AM | Last Updated: 29th
August 2019 08:59 AM

17
Published Articles
Jammu: Operations of 36 medical
stores suspended for ...
https://medicaldialogues.in › ... › Pharma News 07-Mar-2021
— The reasons for suspension ranged from
non-maintenance of sales records,
impersonation, unhygienic and improper
storage conditions, ...

Health Risk from Improper Medication Storage
Antibiotics–if they decay, they can cause stomach or kidney damage.
Aspirin–can cause stomach upset (more than the usual).
Hydrocortisone cream–can separate and become useless in the
heat.
Diagnostic test strips–like those used to test for blood sugar
levels, pregnancy or ovulation, are extremely sensitive to humidity. If
moisture sticks to the strips, it will dilute the test liquid and possible
give a false reading.
Hormone pills–thyroid, birth control and others, are especially
susceptible to temperature changes. These are often protein-based,
and when protein gets hot it changes properties.
Insulin, seizure medicines and anticoagulants–small changes in
doses in some medicines like these can make a big difference to your
health.
Published Articles

• physical instability problems
Oral solutions
Loss of flavour
Change in taste
Presence of off flavours due to
interaction with plastic bottle
Precipitation
discoloration
Effects Change in smell or feel or
taste
19
Physical instability

Parenteral solutions
instability problems
• Discoloration due to photo chemical
reaction or oxidation
• Presence of precipitate due to
interaction with container or stopper
• Clouds due to:
(i) Chemical changes
(ii) The original preparation of a
supersaturated form.
Effects :Change in appearance and in
bio-availability
20

Oral Suspensions
Instability problems
• 1. Settling
• 2. Caking
• 3. Crystal growth
Effects
• Loss of drug content uniformity and loss of elegance.
21

Emulsions
• Creaming: The rise of dispersed particles to the
surface of an emulsion is referred to as creaming,
which occurs due to density differences between the
dispersed particles and the continuous phase.
• Cracking: the separation of two layers of disperse
and continuous phase, Due to the coalescence of
disperse phase globules which are difficult to
redisperse.
22

Semisolids (Ointments and suppositories)
1. Changes in:
a. Particle size
b. Polymorphic state, or hydration or solvation state
c. Consistency
d. Drug release rate
2. Caking or coalescence. Irreversible phase separation.
3. Bleeding loss of structure and viscosity
Effects
• Loss of drug content uniformity, loss of elegance and change
in drug release rate.
23

Suppositories
Effects
• Hardness or shrinkage
• Loss of drug content uniformity,
• loss of elegance and
• change in drug release rate.
24

Uncoated Tablet
• Changes in disintegrarion/ dissolution time/Change in
hardness/change in appearance/ Change in drug release
• Appearance of crystals
• Excessive powder visible
• Discoloration
Coated tablet
• Swell with moisture
Effervecent tablet
• Swell with moisture
25

Gelatin Capsules (Hard and Soft)
Change in
a. Appearance
Harding or softening
b. Capsules sticking together
c. Poor Strength
Effects
• Change in drug release
26

The storage environment should possess
the following:
• Adequate temperature,
• Sufficient lighting,
• Clean conditions,
• Humidity control,
• Cold storage facilities,
• Adequate racks and cupboards to
ensure quality and integrity of the
stored drugs.
28
Environmental factors
Drug Storage Environment

Factors Affecting Product Stability
Microbial contamination
Containers and Closures

1. Temperature,
2. Moisture,
3. Light,
4. Oxygen
5. pH,
6. Drug incompatibility,
30

Temperature
•Increase in temperature usually causes a
very pronounced increase in the hydrolysis
rate of drugs in solution
• The rate of chemical reactions
doubles for every 10°C rise in temperature.
31

Temperature Categories
32
Environmental factors -Temperature
Temperature conditions

Storage temperature condition
33

Effect of Moisture (%Relative Humidity)
a. Water catalyses chemical reactions as
oxidation, hydrolysis and reduction
b. Water promotes microbial growth.
Packing materials such as Glass and Plastic are usually
chosen to prevent exposure of drug product to high
humid conditions
35
The typical storage conditions for pharmaceuticals at room
temperature should be kept between 15 °C and 25 °C (59 °-77
°F) with relative humidity levels somewhere between 30% and
50%.

Effect of Light:
• Light affects drug stability through its energy or
thermal effect which lead to oxidation.
• As a result there will be a loss of potency of the
drug, often accompanied by changes in the
appearance of the product, such as
discoloration or formation of a precipitate.
36

Light sensitive drugs:
• Antibiotics (ciprofloxacin, doxycycline,
levofloxacin, ofloxacin, tetracycline,
trimethoprim)
• Antifungals (flucytosine, griseofulvin,
voricanozole)
• Many pharmaceutical compounds, including the
phenothiazine tranquillizers, hydrocortisone,
prednisolone, riboflavin, ascorbic acid and folic
acid, degrade when exposed to light.
37

• Relationship between wavelength and
associated energy of various forms of light.
Type of
radiation
board outers
Wavelength (nm) Energy
Kcal/mol
U.V.
Short wavelength
50 – 400 Degrade the drug
below 450 nm.
Visible 400 – 750 287 – 72
IR 750 – 10,000 36 - 1
38

Photolysis is prevented by:
Suitable packing in amber colored bottles
Card board outers
Aluminum foil wrappers

Influence of pH
• Most of the drugs degrade at
extreme pHs. ie. At high H+ and
OH- because they are the catalytic
species and accelerate the rate of
hydrolytic decomposition.
• Ionic species degrade at a faster
rate than the neutral/ unionized
species because the ionic species
are more water soluble & prone to
chemical reaction.
• The optimum pH for maximum
stability is 3.5 to 5.0

• Some buffers such as acetate, citrate,
lactate, phosphate and ascorbate
buffers are utilized to prevent drastic
changes in pH.
• Sometimes pH can have a very serious
effect on decomposition. As little as 1
pH unit change in pH can cause a
change of ten fold in rate constant. So
when we are formulating a drug into a
solution, we should carefully prepare a
pH – decomposition profile and then
formulate the solution at a pH, which
is acceptable physiologically and
stability wise also.
41

Effect of Oxygen
• Molecular oxygen is involved in
many oxidation schemes
• Particular drug is likely to be
affected by oxidative breakdown
Prevention by
• Replacing the oxygen in the
storage containers with nitrogen
or carbon oxide
• Avoiding contact with heavy
metal ions
• Adding antioxidants
42

Hydrolysis
• Drug degradation that involves reaction with water
is called hydrolysis
• Hydrolysis is frequently catalysed by hydrogen ions
(specific acid-catalysis) or hydroxyl ions (specific base-
catalysis) and also by other acidic or basic species that
are commonly encountered as components of buffers.
43

Some functional groups subject to Hydrolysis
Drug type Examples
Esters Aspirin, alkaloids, Dexmethasone, Nitroglycerin
Lactones Pilocarpine Spironolactone
Amides Chloramphenicol
Imides Glutethimide
Malonic ureas Barbiturates
44

Isomerization
Isomerization is the conversion of one isomer into another.
This is also known as rearrangement reaction.
Conversion of an active drug into an inactive or a less active
drug is known as isomerization.
Different isomers of a drug often have differing
pharmacological activity or toxicity. so, any change in the
proportion of isomers on storage of a pharmaceutical
product is of importance.
Eg. betamethasone-17-valerate, Amphotericin B.
Cephalosporin 45

Racemization
• The conversion of an optically active
molecule with one chiral center into
its mirror-image is known as racemization.
• Racemization is a major consideration in pharmaceutical stability.
• Optical activity of a compound may be monitored by polarimetry
and reported in terms of specific rotation.
• The racemization of pharmacologically active agents is of
interest because enantiomers often have significantly different
absorption, distribution, metabolism, and excretion, in addition
to differing pharmacological actions.
46

Epimerization
• In drug molecules with
more than one chiral
Centre, racemization at one
of the chiral centers is
known as Epimerization.
• The epimer of tetracycline,
epitetracycline, has little or
no antibacterial activity
47

Polymerization
• Reaction of a drug molecule with another
molecule of the same drug may result in the
formation of a dimer or polymer.
• drugs that undergo polymerization during storage
in solution, for example concentrated aqueous
solutions of Amino-penicillins, Ampicillin sodium.
• Such polymeric substances have been shown to
be highly antigenic in animals.
48

Microbial factors

Microbial factors
Microbiological stability
•Microbiological deterioration is a critical
factor in the stability of sterile products
once the container is opened.
•Deterioration due to microorganism can either render the
product harmful to the patient or have an adverse effect
on the product’s properties.
•Injection products generally need to be used immediately
the container is opened and products for use in the eye
have a short in-use life once opened

1. Contamination from microorganisms is a big problem
for all formulations containing moisture .
2. it can be a bother in solid dosage forms also if some
natural polymers are used because many natural
polymers are fertile sources of microorganisms.
3. In the type of hygienic manufacture carried out today
where “Quality Assurance” is a prerequisite as per the
GMP procedures, there are definite procedures to
prevent microbial contamination in all formulations.
51
Microbial factors

Source of microbial contamination
Gums Actinomyces
Animal products Salmonella, Coliforms
Personnel Coliforms, Staphylococci,
Sterptococci
Water gram-negative groups: Pseudomonas,
Xanthamonas, Flavobacterium
Air Mould spores: Penicillium, Aspergillus
Bacterial spores: Bacillus spp. Yeasts
Raw materials Micrococci
Starches Coliforms
Pigments Salmonella
52
Microbial factors

Product stability can be maintained by addition of following
excipients in formulation.
• Antioxidants: a substance that inhibits oxidation, especially one
used to counteract the deterioration of products. Eg. Ascorbic acid
and sodium thiosulfate
• Antimicrobial preservatives: an additive used to protect against
decay, discoloration, or spoilage. Eg. Benzoic Acid, Benzalkonium
Chloride, Benzyl Alcohol, Methylparaben
• Buffering agent: Buffering agents are widely used to stabilize the
pH of solutions. Eg. Acetates , Citrates, Phosphates
• Chelating agents: A chelating agents are chemical compounds that
reacts with metal ions to form stable, water-soluble metal
complexes. • The chelating agent's molecules form several bonds
to a metal ion and prevent the metal from reacting to other
components of formulation eg. Disodium Edetate (EDTA)
Product Stability

TYPES OF PACKAGING
1. Primary packaging
2. Secondary packaging
3. Tertiary packaging

Types of Glass
1. TYPE I or Highly resistance borosilicate glass
2. TYPE II or Treated soda lime glass
3. TYPE III or Soda lime glass
4. TYPE IV or General purpose soda lime glass
TYPE OF GLASS PROPERTIES SUITABILITY
Type I Alkalinity is removed Parenteral preparation
Type II Treating the surface of type III glass by sulphur dioxide
Acidic buffered solution
Type III It is alkaline glass Dry powder and oleaginous solution
Type IV Similar in composition to that of type III glass Non
parenteral application
55

Glass containers :
Glass is resistant to chemical and physical
change and is the most commonly material
used for packaging of products.
Limitations Overcome
1. Its alkaline surface use of Borosilicate glass
2. Ions may precipitate
insoluble crystals from the glass
the use of buffers
3- Permits the transmission of
light which may accelerate
decomposition.
Amber colored glass
56

PLASTIC CONTAINERS
• There are several different types of
plastics used in pharmaceutical
packaging, including:
PET: polyethylene terephthalate
HDPE: high-density polyethylene
PP: polypropylene
Polystyrene
Polyvinyl chloride (PVC)
57

Drawback of Plastic containers:
• Permeation: The transmission of gases,
vapors or liquids in either direction
through plastic container is known as
“Permeation”.
• Leaching: Leaching of constituents from
plastic into the product
• Sorption: Sorption/Absorption of drug
molecules/ions on the plastic materials
• Alteration on the properties of plastics or product
• Poor printing
58

Metal Containers
Various alloys and aluminum tubes
may be utilized as containers for
emulsions, ointments, creams and
pastes.
Limitation: They may cause corrosion
and precipitation in the drug
product.
Overcome: Coating the tubes with
polymers may reduce these
tendencies.
59

RUBBER CLOSURES:
• Rubber is used mainly for the
construction of closure meant for vials,
transfusion fluid bottles, dropping bottles and as
washers in many other types of product.
Drawbacks of rubber closures:
• Rubber also has the problems of sorption of drug
ingredients and leaching of closure ingredients.
• The pre-treatment of rubber vial stoppers and
closures with water and steam reduces potential
leaching.
60

BUTYL RUBBER:
Advantages:
•impermeability to water vapor .
•Water absorption is very low.
•They are relatively cheaper compared to
•Other synthetic rubbers.
Disadvantages:
•Slow decomposition takes place above 130 ▫ C.
•Oil and solvent resistance is not very good.
NITRILE RUBBER:
Advantages : Oil resistant due to polar nitrile group.
Heat resistant.
Disadvantages: Absorption of bactericide and leaching of
extractives are considerable.

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