ASSIGNMENT 02: DRUG STABILITY Name: Shivam Dubey Physical Pharmaceutical – II Instructor Name: Dr. Shivam Tayal Date: 20/04/2020 ---------------------------------------------------------------------------------------------- Drug Stability Drug stability implies the capacity of the pharmaceutical measurements structure to keep up the physical, synthetic, restorative and microbial properties during the time of capacity and utilization by patients.

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ASSIGNMENT 02: DRUG STABILITY
Name: Shivam Dubey
Physical Pharmaceutical – II
Instructor Name: Dr. Shivam Tayal
Date: 20/04/2020

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Drug Stability
Drug stability implies the capacity of the pharmaceutical measurements
structure to keep up the physical, synthetic, restorative and microbial
properties during the time of capacity and utilization by patients.
It is measured by the pace of changes that take place in pharmaceutical
measurements structures.
Expiry Date
It implies that medication can not be utilized after this date on the grounds
that the concentration of medication diminished and become lower than
remedial concentration.
Instability may cause Undesired change in execution; for example
disintegration/bioavailability.
Factors Affecting Drug Stability
Natural Components
➢ Temperature
High temperature quicken oxidation, decrease and hydrolysis response
which lead to sedate corruption.
➢ Drugs or excipients in measurement structure
- Particle size of the essential medication
- pH of the vehicle .
• Acidic and basic pH impact the rate of decay of most medications.
• Many medications stable between pH 4 and 8.
➢ Moisture
Water catalyze substance responses as oxidation, hydrolysis what's more,
decrease + advances microbial development

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➢ Light
It influence solidness through its vitality or warm impact.
➢ Pharmaceutical measurement structures
It’s strong dose frames more stable than fluid measurement structures
➢ Fixation
The pace of medication corruption is steady for the arrangements of a
similar medication with various conc.
➢ Medication contradiction
The responses between segments of measurements structure or among
segments and front of holder.
➢ Oxygen
Exposure of medication details to oxygen influences steadiness.
Types Of Stability
1. Physical Stability
2. Chemical Stability
3. Microbiological Stability
Physical Stability
The plan is absolutely unaltered all through its timeframe of realistic
usability and has not endured any progressions by method for appearance,
organoleptic properties, hardness, weakness, molecule size .
It is critical as it influences:
o Pharmaceutical polish
o Medicate content consistency

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o Medicate discharge rate.
Physical dangers prospects are:
1. Crystal Arrangement: Polymorphism phenomena(eg; Chloramphenicol
change of shapeless to crystalline structure.
2. Loss of unpredictable substances from pharmaceutical dose structures: Eg;
Aromatic waters, Elixirs. Spirits
3. Loss of water: in Saturated sol., Emulsions, Creams
Humectants as hydrophilic subs included e.g; Glycerin
4. Ingestion of water: (Powders: Liquification , Suppositories which base
produced using Glycerin, Gelatin, becomes jam like appearance
Chemical Stabiity
It infers:
1. The absence of any disintegration in the substance moiety that is
fused in the definition as the medication, additives or some other
excipients.

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2. This decay may impact the physical and concoction dependability of
the medication
Microbiological Stability
Microbiological dependability infers that:
1. The plan has not experienced any microbiological attack& is fulfilling
the guidelines with regard to absence of tainting/sterility.
Prevent Contamination To The
Pharmaceutical Formulation During
Storage:
1. Appropriately planning the holders.
2. Usually utilizing single portion compartments.
3. Sticking to appropriate capacity conditions.
4. Adding an antimicrobial substance as.
Bundling And Its Stability
Plastics
The issues with plastic are:
1. Movement of medication through the plastic into the earth.
2. Move of natural dampness, oxygen, and different components into the
pharmaceutical item.
3. Filtering of compartment fixings into medicate.
4. Adsorption of dynamic medication or excipients by plastic.
Metals
o Different amalgams and aluminum tubes used as compartments for
emulsions, balms, creams glues

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o Constraint: They may cause erosion and precipitation in the
medication item.
o Survive: Coating the cylinders with polymers may decrease these
propensities.
Rubbers
o Elastic additionally has the issues of extraction of medication fixings
and filtering of compartment fixings.
o The pretreatment of elastic vial plugs and terminations with water and
steam decreases potential filtering.
References
o http://lms.itmuniversity.ac.in/mod/resource/view.php?id=40625
o http://lms.itmuniversity.ac.in/mod/resource/view.php?id=41181
o https://www.researchgate.net/publication/286929646_Stability_of_Dr
ugs
o https://www.slideshare.net/SwatiBharati1/drug-stability-71189687
o http://cst-kh.edu.ps/staff/mabujamee/wp
content/uploads/2010/10/Unit-4-Drug-Stability.pdf
o https://www.ncbi.nlm.nih.gov/pubmed/21083197