PHARMACEUTICS I CPH Lecture 2 1

PHARMACEUTICS I
CPH
BY
WANDIRA GONZANI
STABILITY
STABILITY; is the capacity of a drug product to remain within
specifications established to ensure its identity, strength quality and purity.
Or the ability of the pharmaceutical dosage form to maintain the physical,
chemical, therapeutic and microbial properties during the time of storage and
usage by the patient.
Or is the extent to which a product retains the specified limits and through out
its period of storage and use.
FACTORS AFFECTING STABILITY
EXTRINSIC FACTORS/ INTRINSIC FACTORS / boundary

ENVIRONMENTAL DRUG RELATED FACTORS
FACTORS
Temperature PH Dosage form of the drug
Light Drug incompatibility Container composition
Moisture Complexation Porosity
Oxygen concentration
Microbial growth
DRUG STABILITY CONTINUATION
• 1-Temperature: High temp. accelerate oxidation, reduction &
hydrolysis reactions which lead to drug degradation
• PH. Acidic & alkaline pH influence the rate of decomposition of most drugs, Many
drugs stable between pH 4 & 8
• Moisture ; Water catalyze chemical reactions as oxidation, hydrolysis and reduction reaction
• Light affect stability through its energy or thermal effect
• Pharmaceutical dosage form; Solid dosage forms more stable than liquid dosage forms
• Concentration ; rate of drug degradation is constant for solutions of the same drug with
different concentration So ratio of degraded part in diluted sol. Is bigger than in of concentrated
Sol
DRUG STABILITY CONT’D
• Drug incompatibility ; Reactions between components of
pharmaceutical dosage form itself or between components and cover
of container
• Oxygen ; Exposure of drug formulations to oxygen affect their
stability
ENHANCEMENT OF STABILITY
• This can be achieved through addition of ;
• Anti oxidant
• Preservatives
• Chelating agent
• Buffering agents
•
TYPES OF STABILITY
• Chemical stability
• Physical stability
• Microbiological stability
• Therapeutic stability
• Toxicological stability
CHEMICAL STABILITY
• The formulation is totally unchanged throughout its shelf life and has not suffered any
changes by way of appearance, organoleptic properties, hardness, brittleness, particle size i.e.
Each active ingredient retains its chemical integrity and labeled potency within the specified
limits
• It affects ; pharmaceutical elegance , drug content uniformity and drug release rates.
• It is important in selecting the storage conditions, packaging materials , anticipating
interaction when mixing drugs
• Chemical instabilities include ; hydrolysis , oxidation, isomerism , photochemical
decomposition , and polymerization
PHYSICAL STABILITY
• Ability of a drug to maintain its physical dimensions and properties when
exposed to conditions normally encountered in environment i.e. The physical
properties to be maintained include ; appearance , dissolution , uniformity ,
taste , color , suspend-ability etc.
• Physical instabilities may be due to crystal formation , loss of water ,
absorption of water , change in crystalline form ,
Microbiological stability
• The formulation has not suffered from any microbiological attack and is meeting
the standards with respect to lack of contamination/sterility or
• Sterility or resistance to microbial grow this retained to the specifies requirements
• Sources of contaminations include ; water , air , raw materials , personnel and
instruments , containers and closures
• Parenteral considered as one class in microbiological stability & the
rest of drug formulation as one class
• Parenteral either terminally sterilized or manufactured by aseptic
procedure
Therapeutic and toxicological stability
• Therapeutic stability is the ability of a drug to maintain its therapeutic
importance and effectiveness
• Toxicological stability ; this is where there is no significant increase in drug
toxicity during storage of formulation
Stability testing
• Routine procedure performed on drug substance and products at different stages of
production. Or
• Is the process that is used to determine the quality of drug substance or drug product over a
period of specified time under specified environmental conditions.
• On solutions , the following tests can be done on them ; clarity, viscosity , physical
appearance/ colour , odor etc
• Tablets ; hardness test, size and shape , uniformity of weight , colour stability, weight
variations , Friability, dissolution test etc.
• Parenteral ; sterility testing , Pyrogene testing , isotonicity, visual checks/ clarity assays ,
content uniformity , etc
LABORATORY
LABORATORY TERMS USED
• Laboratory ; is a room or building equipped for scientific experiment research or teaching or
for manufacture of drugs or chemicals or is a facility that provides controlled conditions in
which scientific or technological research , experiments and measurement maybe performed
• Safety ; is a condition of being protected from danger or a state in which hazards and
conditions leading to physical , pshychological or material harm are controlled in order to
preserve the health and well being of individuals and the community
• Hazard / Hazardous material; is any source of potential damage , harm or adverse health
effects on something or some one else.
• Accident ; is any un expected event that results in serious injury or illness / Is un fortunate
incident that happens un expectedly and unintentionally resulting into damage or injury.
Terms used cont’d
• Caustic ; this refer to a chemical or substance that is able to burn or corrode organic tissue
by chemical reaction
• Corrosive ; Any substance that causes damage by chemical reaction
• Toxicity ; this refer to the degree to which chemical substances or can damage an organism.
• Precaution ; is a warning or caution employed to prevent a misfortune or something
dangerous from happening
• Prevention ; Is the action taken to decrease the chances of getting a disease, injury ,
condition/ Ay measure intended to limit health related risks.
• First aid ; Help given to a sick or injured person until full medical treatment is available.
IMPORTANCES OF LABORATORY
• It protects environment from the pollution of the by chemicals
• It provides a standardized environment for carrying out culture and
sensitivity
• Provide a controlled environment for drug manufacture
• Aid in research during drug discovery
• Labs provide students with various opportunities to learn and experiment
BARRIERS TO SAFE AND EFFECTIVE
PRACTICE OF
LABORATORY/CHEMICAL SAFETY
• Lack of enough space in the laboratory which causes congestion in the laboratory
• Lack of enough water supply within the laboratory
• Shortage of instructors or others who can train new students and staff
• the cost or limited availability of safety and security equipment within the laboratory
• cultural beliefs that minimize the importance of individual health and safety
• Environmental conditions such as climate changes which make compliance difficult
• Lack or variable experience among the students , supervisors and staff within the
laboratory
QUALITIES OF AN IDEAL LABORATORY
• Should be well organized so as not to mix chemicals with materials

• It should have enough space to avoid congestion
• Should be well ventilated
• Should have a qualified personnel
• Good storage facilities for different chemicals and materials that need
different storage conditions
• It should be designed to promote efficient work flow

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PHARMACEUTICS I

EXTRINSIC FACTORS/ INTRINSIC FACTORS / boundary

• Should be well organized so as not to mix chemicals with materials

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