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Causes of degradation and potential adverse effect of instability in pharmaceuticals product
- 2. Presentation on CAUSES OF DEGRADATION AND POTENTIAL ADVERSE EFFECT OF INSTABILITY IN PHARMACEUTICALS PRODUCT
- 3. SUBMITTED BY MOHAMMAD ASHRAFUL ALAM MUNNA Student, Department of Pharmacy Southeast University Bangladesh Email:- monnaskl2750@gmail.com
- 4. What is degradation ?? → The change of a chemical compound into a less complex compound.
- 5. What is Pharmaceutical degradation ??? →Pharmaceutical degradation is a type organic reaction in which a compound is converted into a simpler compound
- 6. Causes of degradation 1.Expiry date of pharmaceutical product. 2.High temperature . 3.PH of vehicle 4.Moisture. 5.Light 6.Oxygen 7.Drug incapability 8. Surfactants 9. Presence of heavy metals. 10.Unprotectable packaging.
- 7. Types of degradation: The major degradation are 3 types. there are 1.Physical degradation 2. Chemical degradation 3. Microbiological degradation
- 8. Physical Degradation Physical degradation involves changes to materials resulting from ambient conditions like sunlight, heat, humidity, exposure to chemicals or general wear and tear. Its form depends on the material
- 9. Causes of physical degradation Many kinds of causes are responsible for physical degradation… • Loss of volatile components • Loss of H2O • Absorption of H2O • Crystal growth • Polymorphic changes • Color changes
- 10. Loss of volatile components: Many drugs and excipients may be lost from pharmaceutical products at ambient temperature through vaporization. they escape from the formulations rendering them degraded. Examples: Iodine, menthol, corpus, chloroform
- 11. Loss of H2O: loss of water may decrees the product stability. that’s why products loss it’s weight. products such as emulsion exhibit cracking. Example: water loos from oil
- 12. Absorption of H2O: Hygroscopic drugs absorb the water from external atmosphere causing the physical degradation. Example: Glycerol and dry plant extract
- 13. Crystal growth : Drugs when loose water, become saturated and crystal growth occurs. Molecules in the crystal are not static, they can grow in size and move when there is a medium to travel. Examples: Carbamazepine tablets
- 14. Color changes: color change indicates some kinds of chemical decomposition of active ingredients Example: aspirin tablets Phenolpthalin
- 15. CHEMICAL DEGRADATION It is the separation of chemical compound into elements or simpler compounds. Change in the chemical nature of the drug is called as chemical degradation.
- 16. Types of chemical degradation There are 5 kinds of chemical degradation 1. Hydrolysis 2. Oxidation 3. Decarboxylation 4. Isomerization 5. Polymerization
- 17. Hydrolysis Drugs with functional groups such as esters, amides, lactones or lactams may be susceptible to hydrolytic degradation. because of the prevalence of such groups in medicinal agents and the ubiquitous nature of water Examples: aspirin , procaine ,ampicillin
- 18. Oxidation • Removal of an electropositive atom, radical or electron, or the addition of an electronegative atom or radical. Oxidation has two types · Auto-oxidation · Photo-oxidation
- 19. Decarboxylation Elimination of CO2 from a compound .Drug substances having a carboxylic acid group are sometimes susceptible to decarboxylation. Example:4-amino salicylic acid
- 20. ISOMERIZATION It is the process by which one molecule is transformed into another molecule which has exactly the same atoms, but the atoms are rearranged different. Some like this: A-B-C → B-A-C • Types of Isomerization: 1) Optical Isomerization 2) Geometrical Isomerization
- 21. POLYMERIZATION Combination of two or more identical molecules to form a much larger and more complex molecule. • Example: Formaldehyde solution may result into formation of white deposit when stand in cold.
- 22. MICROBIAL DEGRADATION • Contamination of a product may sometimes cause a lot of damage and sometimes may not be anything at all. Thus it is dependent on the type of microbe and its level of toxicity it may produce. If parenteral or ophthalmic formulations are contaminated, it may cause serious harm. Example: Progeny which are the metabolic products of bacterial growth are usually lipo polysaccharides and they represent a particularly hazardous product released by gram negative bacteria. If administered inadvertently to a patient they may cause chills and fever.
- 23. Meaning of drug instability The incapacity or incapability of a particular formulation in a specific container to remain within a particular chemical, microbiological, therapeutically, physical & toxicological specification.
- 24. Adverse effects of instability of drugs and effect Loss of active drug (e.g. aspirin hydrolysis, oxidation of adrenaline). Loss of vehicle (e.g. evaporation of water from o/w creams, evaporation of alcohol from alcoholic mixtures). Loss of content uniformity (e.g. creaming of emulsions, impaction of suspensions). Loss of elegance (e.g. fading of tablets and colored solutions). Reduction in bioavailability (e.g. ageing of tablets resulting in a change in dissolution profile). Production of potential toxic materials (e.g. breakdown
- 25. Prevention: We can preventing instability in different way. As a result we stable pharmaceutical product in long time.
- 26. PREVENTION: 1. Such product should be placed in well closed container. 2. Temperature should be proper. 3. Water loss to the atmosphere can be prevented by storing the pharmaceutical product in a well closed container. 4. Powder Products should be placed in well-closed container and in dry place. 5. PH should be adjusted. 6. Exposure to light should be avoided. 7. An attempt has been made to prevent the fading by incorporating UV light absorbing material. 8. Suitable packing in amber colored bottles. 9. Cardboard outers. 10. Aluminium foil over wraps.
- 27. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Oral solutions 1- Loss of flavour 2- Change in taste 3- Presence of off flavours due to interaction with plastic bottle 4- Loss of dye 5- Precipitation 6- discoloration Change in smell or feel or taste
- 28. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Suspensions 1- settling 2- caking 3- crystal growth 1-Loss of drug content uniformity in different doses from the bottle 2- loss of elegance.
- 29. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Emulsions 1- Creaming 2- coalescence 1- Loss of drug content uniformity in different doses from the bottle 2- loss of elegance
- 30. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Tablets Change in: a) Disintegration time b) Dissolution profile c) Hardness d) Appearance (soft and ugly or become very hard) Change in drug release
- 31. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Capsules Change in: a) Appearance b) Dissolution c) Strength Change in drug release
- 32. Adverse effects of instability of drugs Formulation Likely physical instability problems Effects Semisolids (Ointments and suppositories) 1. Changes in: a) Particle size b) Consistency 2. Caking or coalescence 3. Bleeding 1-Loss of drug content uniformity 2- loss of elegance 3-change in drug release rate.
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