Degradation process of pharmaceutical product

1. DEGRADATION PROCESS OF
PHARMACEUTICAL PRODUCT
PRESENTED
BY
MD. IMRAN HOSSAIN

2. CONTENT
• DEGRADATION & DEGRADATION PRODUCT
• PHARMACEUTICAL DEGRADATION
• TYPES OF DEGRADATION
• CONCLUSION

3. DEGRADATION &
DEGRADATION PRODUCT
• THE CONDITION OR PROCESS OF DEGRADATION OR BEING DEGRADED.
• DEGRADATION PRODUCTS ARE UNWANTED CHEMICALS THAT CAN DEVELOP DURING THE
MANUFACTURING, TRANSPORTATION AND STORAGE OF DRUG PRODUCTS AND CAN AFFECT
THE EFFICACY OF PHARMACEUTICAL PRODUCTS.

4. PHARMACEUTICAL
DEGRADATION
• THE INCAPACITY OR INCAPABILITY OF A
PARTICULAR FORMULATION IN A SPECIFIC
CONTAINER TO REMAIN WITHIN A PARTICULAR
CHEMICAL, MICROBIOLOGICAL,
THERAPEUTICALLY, PHYSICAL AND
TOXICOLOGICAL SPECIFICATION.

5. TYPES OF DEGRADATION
•DEGRADATION ARE TWO TYPES:
PHYSICAL DEGRADATION
CHEMICAL DEGRADATION

6. PHYSICAL DEGRADATION & TYPES
• PHYSICAL DEGRADATION INVOLVES CHANGE TO MATERIALS RESULTING
FROM AMBIENT CONDITIONS LIKE SUNLIGHT, HEAT, HUMIDITY, EXPOSURE
TO CHEMICAL OR GENERAL WEAR AND TEAR.
• PHYSICAL DEGRADATION TYPES ARE AS UNDER…….
 LOSS OF VOLATILE COMPONENT
 LOSS OF H2O
 ABSORPTION OF H2O
 CRYSTAL GROWTH
 POLYMORPHIC CHANGES
 COLOR CHANGES

7. LOSS OF VOLATILE
• VOLATILE COMPONENTS SUCH AS ALCOHOL ETHER, IODINE, VOLATILE OILS,
CAMPHOR, METHANOL ETC. ESCAPE FROM THE FORMULATION.
• EXAMPLES:
• AROMATIC WATERS
• ELIXIRS
• SPIRITS
• SOME TYPES OF TABLETS WHICH CONTAIN AROMATIC WATER (NITROGLYCERIN
TABLETS)

8. LOSS OF H2O
• THIS TENDENCY DEPENDS ON TEMPERATURE AND HUMIDITY OF SURROUNDING
ENVIRONMENT.
• SATURATED SOLUTION: BY LOSS OF WATER THEY BECOME SUPERSATURATED AND
PRECIPITATE AS CRYSTALS IS FORMED.
• EMULSION: LOSS OF WATER LEAD TO SEPARATION OF THE TWO PHASES AMD CHANGE TO
OTHER TYPE.
• CREAMS: ESPECIALLY OIL/WATER, THEY BECOME DRY BY LOSS OF WATER.
• PASTE
• OINTMENT: ESPECIALLY AQUEOUS BASE OINTMENTS.

9. ADSORPTION OF H2O
• HYGROSCOPIC DRUG ABSORB THE WATER FROM EXTERNAL ATMOSPHERE CAUSING THE
PHYSICAL DEGRADATION. DEPENDS ON TEMPERATURE AND HUMIDITY OF SURROUNDING
ENVIRONMENT.
THIS PHENOMENON CAN BE SEEN IN THE FOLLOWING PHARMACEUTICAL FORM:
• POWDERS: LIQUIFICATION AND DEGRADATION MAY OCCUR AS A RESULT OF ABSORPTION OF
WATER.
• SUPPOSITORIES WHICH BASE MADE FROM HYDROPHILIC SUBSTANCES AS GLYCERIN, GELATIN,
AND POLYETHYLENE GLYCOL.
• SOME DELIQUESCENT SALTS CALCIUM CHLORIDE, POTASSIUM CITRATE.
• THE CONSISTENCY OF THESE FORMS BECOMES JELLY LIKE APPEARANCE

10. CHEMICAL DEGRADATION
• CHANGE IN THE CHEMICAL NATURE OF THE DRUG IS CALLED
AS CHEMICAL DEGRADATION. CHEMICAL DEGRADATION OF A
DOSAGE FORM OCCURS THROUGH SEVERAL PATHWAYS LIKE
• HYDROLYSIS,
• OXIDATION,
• PHOTOLYSIS
• DECARBOXYLATION
• ISOMERIZATION
• POLYMERIZATION

11. HYDROLYSIS
• IT IS DEFINED AS THE REACTION OF A COMPOUND WITH WATER.
• MOST IMPORTANT IS SYSTEMS CONTAINING WATER SUCH AS EMULSION, SUSPENSION,
SOLUTIONS ETC.
• ALSO, FOR DRUG WHICH ARE AFFECTED BY MOISTURE (WATER VAPOR) FROM
ATMOSPHERE.
• IT IS USUALLY CATALYZED BY HYDROGEN ION (ACID) OR HYDROXYL ION (BASE).
• IN THIS ACTIVE DRUG IS DECOMPOSED WITH SOLVENT.
• USUALLY SOLVENT IS WATERING SOME TIME REACTION MAY INVOLVE PHARMACEUTICAL
CO-SOLVENTS SUCH AS ETHYL ALCOHOL OR POLY ETHYLENE GLYCOL.
• MAIN CLASSES OF DRUG THAT UNDERGO HYDROLYSIS ARE ESTERS, AMIDE, ALKALI, ACID.
• E.G. ASPIRIN- ASPIRIN DEGRADE INTO SALICYLIC ACID AND ACETIC ACID GIVING VINEGAR
LIKE ODOR.

12. OXIDATION
• REMOVAL OF AN ELECTROPOSITIVE ATOM, RADICAL OR THE ADDITION OF AN ELECTRONEGATIVE
ATOM OR RADICAL.
• OXIDATION IS CONTROLLED BY ENVIRONMENT. I.E. LIGHT, TRACE ELEMENTS, OXYGEN AND
OXIDIZING AGENT.
• OCCURS WHEN EXPOSED TO ATMOSPHERIC OXYGEN.
• EITHER THE ADDITION OF OXYGEN OR REMOVAL OF HYDROGEN.
• OXIDATION IS THE LOSS OF ELECTRONS WHILE REDUCTION IS THE GAIN OF ELECTRONS.
• TYPES:
• AUTO-OXIDATION
• PHOTO-OXIDATION

13. CONCLUSION
• DRUG DEGRADATION WHERE THE BREAKDOWN OF A DRUG IS A
CHEMICAL REACTION INVOLVING THE COLLISION OF MOLECULES.
• THE REACTION ROUTES BY WHICH MOST PHARMACEUTICALS DEGRADE
ARE: HYDROLYSIS, REDUCTION, PHOTOLYSIS, RACEMIZATION AND
DECARBOXYLATION.

14. THANK YOU