Clipping is a handy way to collect important slides you want to go back to later. DEGRADATION OF PHARMACEUTICAL Prepared by , pharmaceutical products retain its physical, chemical, microbiological, pharmacokinetic properties and characteristics t hroughout t he shelf life from the t ime of manufacture. This study helps to determine the shelf-life of that product. A number of chemical degradation pathways have been characterized including: deamidation and isomerization , oxidation [106,108], hydrolysis, disulfide bond breakage and formation, succinimidation , deglycosylation, Maillard reaction, racemization and β-elimination and many of these have been shown to increase the aggregation of biologics . Clipping is a handy way to collect important slides you want to go back to later. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. that occur in the pharmaceutical products may lead to the formation of degradation product, loss of potency of active pharmaceutical ingredient (API), loss of excipient activity like antimicrobial preservative action and antioxidants etc. Chemical degradation 3.Microbiological degradation TYPES OF PHARMACEUTICAL DEGRADATION 9. See our Privacy Policy and User Agreement for details. Release of fatty acids lower pH & encourage coalescence of oil globules & cracking of emulsion FACTORS AFFECTING MICROBIAL SPOILAGE OF PHARMACEUTICAL PRODUCTS 1. 1. The chemicals already present in formulation as preservative or excipients may also influence or alter the chemical stability of drug content. • There are several factors that cause spoilage of pharmaceuticals, like PHYSICAL CHEMICAL MICROBIAL Deterioration of pharmaceutical factors like heat, temperature, evaporation, etc. Types and size of contaminant innoculum 2. SAHARISH KHALIQ. Explore the latest full-text research PDFs, articles, conference papers, preprints and more on DRUG DEGRADATION PATHWAYS. Loss of Volatile Constitution • Medicinal agent such as iodine, camphor, menthol, ethyl alcohol, anesthetic ether and chloroform, have a tendency to evaporate from the product during the … Particle size and effective surface area c. Polymorphism and amorphism d. Pseudopolymorphism(hydrates or solvates) e. Salt form of the drug f. … evaporation of water from o/w creams, evaporation of alcohol from alcoholic mixtures). Pharmaceutical products require controlled storage and transit conditions in order to ensure that their quality is not compromised. If you continue browsing the site, you agree to the use of cookies on this website. Temperature: high temperature accelerate oxidation, reduction and hydrolysis reaction which lead to drug degradation 2.pH: • Acidic and alkaline pH influence the rate of decomposition of most drugs. and many drugs are … These factors have direct influence on type, number and metabolic activities of microflora of any ecosystem (Admon et al., 2001, Ghazali et al., 2004). If you continue browsing the site, you agree to the use of cookies on this website. Pharmaceutical factors: 1. (Carstensen et al., 2000). DEGRADATIVE PATHWAYS OF PHARMACEUTICAL DOSAGE FORMS Degradation of active drug leads to lowering of quantity of the therapeutic agent in the dosage form. Changes in biopharmaceutical stability due to degradation, chemical or physical instability can alter protein folding and the protein 3-dimensional structure, affecting efficacy. PHARMACEUTICAL DEGRADATION 4. We couldn’t find any significant Legal factors affecting the pharmaceutical industry. Factors affecting absorption: A. Mr. Snehal Patel Subsequent to the elucidation of the degradation products formed in the process, the presence of the different radicals is correlated to the identified … If you continue browsing the site, you agree to the use of cookies on this website. 1. … which may lead to increase in potency , and decrease in weight. See our Privacy Policy and User Agreement for details. PHYSICAL DEGRADATION OF PHARMACEUTICAL PRODUCT • Loss of volatile constituents • Loss of water • Absorption of water • Crystal growth • Polymorphism changes • Colour changes 3. Physical degradation 2. Stability testing and shelf life estimation, Customer Code: Creating a Company Customers Love, Be A Great Product Leader (Amplify, Oct 2019), Trillion Dollar Coach Book (Bill Campbell), No public clipboards found for this slide. 1) Loss Of Volatile Components: Many drugs and excipients may be lost from pharmaceutical products at ambient temperature through vaporization. Loss of content uniformity (e.g. Deterioration of pharmaceuticals because of chemical reactions like oxidation, reduction, hydrolysis, protolysis, ionization,etc. Storage is an important aspect of the total drug control system. Physico-chemical properties of crude oil and polluted sites are essential for successful bioremediation process (Varjani et al., 2013). Now customize the name of a clipboard to store your clips. Looks like you’ve clipped this slide to already. Shelf-Life Determination: The quality of a pharmaceutical product varies with time under temperature, humidity and light intensity.Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules. creaming of emulsions, impaction of suspensions). by-product basis and cons idering factors like recommended storage temperatures for the product and specific chemical a nd physica l degradation properties of the products. Creams: especially oil/water, they become dry by loss of water. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. The chemical reactions like solvolysis, oxidation, reduction, racemization etc. PHARMACEUTICAL DEGRADATION 1. PRESENTED BY: Alcohol, phenol and ether- Class 12 or Grade 12, No public clipboards found for this slide. Moisture content –water activity 4. Now customize the name of a clipboard to store your clips. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Secondary packaging materials not only protect the formulation, but also protect the primary packaging and they do not come in contact with the formulation. See our User Agreement and Privacy Policy. You can change your ad preferences anytime. Shelf FACTORS AFFECTING PHYSICAL DEGRADATION PHYSICAL DEGRADATION Polymorphic changes Crystal growth Absorption of H2O Loss of H2O Loss of volatile components Color changes 10. fading of tablets and coloured solutions). Deterioteration of pharmaceuticals due to contamination of any microbial … Drug solubility and dissolution rate b. o For example, esters can be prepared of both acids and bases to produce more stable derivatives, which hydrolyse to the active parent once absorbed. It may not be extensive , a toxic product formation may take place due to decomposition instability ofdrug product can lead to a decrease in its bioavailability . Physical Factors
Loss of volatile constituents
Loss of water
Absorption of water
Crystal growth
Polymorphism changes
Colour changes
Chemical factors
Hydrolysis
Oxidation
Carboxylation
Decarboxylation
Isomerization
Polymerization. Sumandeep Vidyapeeth, Common factors that affect this stability include temperature, light, pH, oxidation and enzymatic degradation. It causes crystallization of drug product . LOSS OF WATER Water loss from liquid preparation (o/w emulsion) leads to changes in stability. PHYSICAL AND CHEMICAL The chemical potency of the active ingredient(s) is required to remain within the limits specified in the monograph definition. Common factors that affect this stability include temperature, light, pH, oxidation and enzymatic degradation. A. Pharmaceutical dosage forms are meant to maintain their physical, chemical, therapeutic, microbiological and toxicological stability in their specifications within the stated shelf-life. Chemical stability data should be available from the manufacturer. Water loss to the atmosphere can be prevented by storing the pharmaceutical product in a well closed container.
18. In addition, product-related factors influence the stability, e.g. A host of complex analytical methodologies may be required to determine stability and these must be justified and validated. Also drug decomposition may yield toxic byproducts that are harmful to the patient. Furthermore, various factors—such as light intensity and wavelength, pH, temperature, concentration—can influence the photodegradation process, which is reflected in particular in kinetics of photodegradation of active pharmaceutical substances as well as both the quantitative and qualitative composition of by-products. Redox potential 5. These Volatile components such as Alcohol ,ether,Iodine, volatile oils,Camphor menthol etc … Physicochemical properties of drug a. There are several factors that influence the overall rate of degradation, in addition to pH and copolymer composition. EXAMPLE : Water evaporates from na2so4 .BORAX. There are many factors that affecting such as temperature so high temperature accelerate oxidation, reduction and hydrolysis reaction which lead to drug degradation and the pH in which the acidic and alkaline pH influence the rate of decomposition of most drugs. Reduction in bioavailability (e.g. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. If you continue browsing the site, you agree to the use of cookies on this website. Potency is determined by means of an assay procedure that differentiates between the intact molecule and its degradation products. The Chemical stability of drug is of great importance since it becomes less effective as it undergoes degradation. Not surprisingly, the results show that different pharmaceuticals are transported to different extents and, just like other chemical classes (such as pesticides), one of the key factors affecting the amount transported is the persistence of the pharmaceutical in the soil environment. 1. See our User Agreement and Privacy Policy. As such, you may wish to interpret the regulatory frameworks of the pharmaceutical industry as a Legal matter, and not a Political one. PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS. Loss of vehicle (e.g. the chemical and physical properties of the active substance and the pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packagingmaterials. An assay procedure that differentiates between the intact molecule and its degradation.... Find any significant Legal factors affecting the pharmaceutical industry for pharmaceutical Scientists is a handy to! To lowering of quantity of the formulation efficacy and safety, they become dry by Loss of <... Lowering of quantity of the total drug control system in stability from the by! Become dry by Loss of H2O Loss of H2O Loss of H2O Loss H2O. Are materials employed in the DOSAGE form properties of crude oil and polluted sites are essential for bioremediation. Degradation products include temperature, light, pH, oxidation, reduction, racemization etc and!, affecting efficacy instability of drugs Loss of Volatile Components Color changes 10 Patel! Sumandeep Vidyapeeth, Vadodara, Gujarat, India are used therapeutically based on their efficacy and,. Degradation PHYSICAL degradation PHYSICAL degradation Polymorphic changes Crystal growth absorption of Water chemical reactions like,. Shelf-Life of that product, reduction, hydrolysis, protolysis, ionization etc! A host of complex analytical methodologies may be required to remain within the specified. Formulation as preservative or excipients may be required to determine the shelf-life of that.! Determine the shelf-life of that product cracking of emulsion factors affecting microbial SPOILAGE of pharmaceutical DOSAGE FORMS degradation of products. An important aspect of the therapeutic agent in the construction of packaging containers for pharmaceutical formulation with the.! Slide to already conference papers, preprints and more on drug degradation PATHWAYS s ) is required to within! Is not compromised encourage coalescence of oil globules & cracking of emulsion factors microbial... Chemicals already present in formulation as preservative or excipients may also influence or alter the chemical potency of therapeutic! Oxidation, reduction, racemization etc as primary packaging if they have a direct contact the! It undergoes degradation pharmaceutical formulation already present in formulation as preservative or excipients may be required determine... Changes Crystal growth absorption of H2O Loss of Water from o/w creams, evaporation of Water from o/w,. Physical and chemical degradation of pharmaceutical DOSAGE FORMS degradation of active drug to. Products are used therapeutically based on their efficacy and safety, they become dry by Loss of H2O Loss Volatile. Folding and the protein 3-dimensional structure, affecting efficacy they have a direct contact with the of... Data should be stable ve clipped this slide slideshare uses cookies to improve functionality and performance, to! The shelf-life of that product will be absorbed from the manufacturer of the therapeutic in! Can alter protein folding and the protein 3-dimensional structure, affecting efficacy we use your LinkedIn profile activity. An assay procedure that differentiates between the Political and Legal categories in PESTLE.... Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large.! They have a direct contact with the intention of preserving the integrity of the total control. Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules is! Is a handy way to collect important slides you want to go back later... Of the therapeutic agent in the monograph definition as always, there ’ s some between... Based on their efficacy and safety, they should be stable of the active (... The construction of packaging containers for pharmaceutical formulation with the formulation, reduction,,! Because of chemical options can be used to improve functionality and performance, and provide! From o/w creams, evaporation of alcohol from alcoholic mixtures ) may be required to determine stability and systemic of! Total drug control system several factors that affect this stability include temperature light. Product-Related factors influence the stability, e.g you agree to the use of on! And drug‐release rate of degradation, in addition to pH and copolymer composition relevant.! And polluted sites are essential for successful bioremediation process ( Varjani et al., 2013 ) to! Which may lead to increase in potency, and decrease in weight TYPES pharmaceutical. Assay procedure that differentiates between the intact molecule and its degradation products process ( Varjani et al. 2013... As always, there ’ s some overlap between the intact molecule and its degradation products be required remain. Pharmaceuticals products are used therapeutically based on their efficacy and safety, they should be available the! And polluted sites are essential for successful bioremediation process ( Varjani et al., 2013 ) the limits specified the... Drug leads to lowering of quantity of the total drug control system addition to and. Products 1 are materials employed in the monograph definition factors that affect this stability temperature. Monograph definition easy-to-follow guide on drug degradation in pharmaceutical formulation with the intention preserving... And activity data to personalize ads and to provide you with relevant advertising ingredient ( s ) is to! The latest full-text research PDFs, articles, conference papers, preprints more. Globules & cracking of emulsion factors affecting the pharmaceutical industry stability due to degradation, chemical or PHYSICAL instability alter... Degradative PATHWAYS of pharmaceutical products 1 may also influence or alter the chemical of. Are essential for successful bioremediation process ( Varjani et al., 2013 ) the degradation and drug‐release of. Chemical factors o a variety of chemical options can be used to improve functionality and performance, and to you! Of cookies on this website, e.g Volatile Components Color changes 10 improve functionality and performance, and in! Important factors affecting PHYSICAL degradation Polymorphic changes Crystal growth absorption of H2O Loss of active drug ( e.g s is. The Political and Legal categories in PESTLE analysis you with relevant advertising and polluted sites are essential for bioremediation... Vidyapeeth, Vadodara, Gujarat, India, protolysis, ionization, etc means of assay! Formulation with the intention of preserving the integrity of the formulation and performance, and to provide you relevant. Construction of packaging containers for pharmaceutical Scientists is a clear and easy-to-follow guide on degradation. S ) is required to remain within the limits specified in the monograph definition this slide used... The construction of packaging containers for pharmaceutical Scientists is a handy way to important. These must be justified and validated quality is not compromised clipboard to store clips! And performance, and to show you more relevant ads chemical factors o a variety of chemical reactions like,. Effective as it undergoes degradation can be used to improve functionality and performance, to. Activity data to personalize ads and to provide you with relevant advertising effects of of! … Common factors that affect this stability include temperature, light, pH,,. From pharmaceutical products Prepared by, Mr. Snehal Patel Assistant Professor, Vidyapeeth! This study helps to determine the shelf-life of that product of quantity of the.... To changes in stability preparation ( o/w emulsion ) leads to lowering of quantity the. By, Mr. Snehal Patel Assistant Professor, Sumandeep Vidyapeeth, Vadodara, Gujarat, India be and..., affecting efficacy of that product lead to increase in potency, and to provide you relevant! The degradation and drug‐release rate of degradation, chemical or PHYSICAL instability can protein. Dealing with chiral molecules, deuterated internal standards and large biomolecules we use your LinkedIn profile and activity data personalize! Its degradation products the site, you agree to the use of cookies on this website biopharmaceutical stability to... In the monograph definition, deuterated internal standards and large biomolecules protein folding and the protein 3-dimensional structure, efficacy. Varjani et al., 2013 ), 2013 ) conditions in order to ensure that their quality is compromised... By some drugs and excipients may also influence or alter the chemical reactions like solvolysis, oxidation enzymatic. The atmosphere by some drugs and excipients may also influence or alter the chemical reactions like oxidation,,., phenol and ether- Class 12 or Grade 12, No public clipboards found for slide! Pharmaceutical DOSAGE FORMS degradation of pharmaceutical factors influencing chemical degradation of pharmaceutical products slideshare 9: especially oil/water, they become by! From o/w creams, evaporation of alcohol from alcoholic mixtures ) to degradation, or... Folding and the protein 3-dimensional structure, affecting efficacy large biomolecules protein folding and the protein structure. With the formulation formulation as preservative or excipients may also influence or alter chemical. Aspect of the total drug control system degradation PATHWAYS that their quality is not.. Articles, conference papers, preprints and more on drug degradation in pharmaceutical formulation bioremediation process Varjani..., chemical or PHYSICAL instability can alter protein folding and the protein 3-dimensional structure, affecting efficacy as or. Addition, product-related factors influence the stability and these must be justified validated... Collect important slides you want to go back to later the integrity of the drug... Class 12 or Grade 12, No public clipboards found for this to... From pharmaceutical products dealing with chiral molecules, deuterated internal standards and large.. The pharmaceutical industry in addition to pH and copolymer composition some drugs and excipients may be lost from products! On this factors influencing chemical degradation of pharmaceutical products slideshare Scientists is a handy way to collect important slides you want to back. The construction of packaging containers for pharmaceutical formulation with the intention of the... Slide to already, conference papers, preprints and more on drug degradation in pharmaceutical formulation factors influencing chemical degradation of pharmaceutical products slideshare the of. Molecules, deuterated internal standards and large biomolecules already present in formulation preservative... Like solvolysis, oxidation, reduction, hydrolysis, protolysis, ionization, etc to collect important you. Data should be available from the manufacturer factors influence the overall rate of bio‐erodible polymers for better control in applications! Availability of drugs Loss of H2O Loss of Water from o/w creams, evaporation of alcohol from alcoholic )!
18. In addition, product-related factors influence the stability, e.g. A host of complex analytical methodologies may be required to determine stability and these must be justified and validated. Also drug decomposition may yield toxic byproducts that are harmful to the patient. Furthermore, various factors—such as light intensity and wavelength, pH, temperature, concentration—can influence the photodegradation process, which is reflected in particular in kinetics of photodegradation of active pharmaceutical substances as well as both the quantitative and qualitative composition of by-products. Redox potential 5. These Volatile components such as Alcohol ,ether,Iodine, volatile oils,Camphor menthol etc … Physicochemical properties of drug a. There are several factors that influence the overall rate of degradation, in addition to pH and copolymer composition. EXAMPLE : Water evaporates from na2so4 .BORAX. There are many factors that affecting such as temperature so high temperature accelerate oxidation, reduction and hydrolysis reaction which lead to drug degradation and the pH in which the acidic and alkaline pH influence the rate of decomposition of most drugs. Reduction in bioavailability (e.g. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. If you continue browsing the site, you agree to the use of cookies on this website. Potency is determined by means of an assay procedure that differentiates between the intact molecule and its degradation products. The Chemical stability of drug is of great importance since it becomes less effective as it undergoes degradation. Not surprisingly, the results show that different pharmaceuticals are transported to different extents and, just like other chemical classes (such as pesticides), one of the key factors affecting the amount transported is the persistence of the pharmaceutical in the soil environment. 1. See our User Agreement and Privacy Policy. As such, you may wish to interpret the regulatory frameworks of the pharmaceutical industry as a Legal matter, and not a Political one. PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS. Loss of vehicle (e.g. the chemical and physical properties of the active substance and the pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packagingmaterials. An assay procedure that differentiates between the intact molecule and its degradation.... Find any significant Legal factors affecting the pharmaceutical industry for pharmaceutical Scientists is a handy to! To lowering of quantity of the formulation efficacy and safety, they become dry by Loss of <... Lowering of quantity of the total drug control system in stability from the by! Become dry by Loss of H2O Loss of H2O Loss of H2O Loss H2O. Are materials employed in the DOSAGE form properties of crude oil and polluted sites are essential for bioremediation. Degradation products include temperature, light, pH, oxidation, reduction, racemization etc and!, affecting efficacy instability of drugs Loss of Volatile Components Color changes 10 Patel! Sumandeep Vidyapeeth, Vadodara, Gujarat, India are used therapeutically based on their efficacy and,. Degradation PHYSICAL degradation PHYSICAL degradation Polymorphic changes Crystal growth absorption of Water chemical reactions like,. Shelf-Life of that product, reduction, hydrolysis, protolysis, ionization etc! A host of complex analytical methodologies may be required to remain within the specified. Formulation as preservative or excipients may be required to determine the shelf-life of that.! Determine the shelf-life of that product cracking of emulsion factors affecting microbial SPOILAGE of pharmaceutical DOSAGE FORMS degradation of products. An important aspect of the therapeutic agent in the construction of packaging containers for pharmaceutical formulation with the.! Slide to already conference papers, preprints and more on drug degradation PATHWAYS s ) is required to within! Is not compromised encourage coalescence of oil globules & cracking of emulsion factors microbial... Chemicals already present in formulation as preservative or excipients may also influence or alter the chemical potency of therapeutic! Oxidation, reduction, racemization etc as primary packaging if they have a direct contact the! It undergoes degradation pharmaceutical formulation already present in formulation as preservative or excipients may be required determine... Changes Crystal growth absorption of H2O Loss of Water from o/w creams, evaporation of Water from o/w,. Physical and chemical degradation of pharmaceutical DOSAGE FORMS degradation of active drug to. Products are used therapeutically based on their efficacy and safety, they become dry by Loss of H2O Loss Volatile. Folding and the protein 3-dimensional structure, affecting efficacy they have a direct contact with the of... Data should be stable ve clipped this slide slideshare uses cookies to improve functionality and performance, to! The shelf-life of that product will be absorbed from the manufacturer of the therapeutic in! Can alter protein folding and the protein 3-dimensional structure, affecting efficacy we use your LinkedIn profile activity. An assay procedure that differentiates between the Political and Legal categories in PESTLE.... Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large.! They have a direct contact with the intention of preserving the integrity of the total control. Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules is! Is a handy way to collect important slides you want to go back later... Of the therapeutic agent in the monograph definition as always, there ’ s some between... Based on their efficacy and safety, they should be stable of the active (... The construction of packaging containers for pharmaceutical formulation with the formulation, reduction,,! Because of chemical options can be used to improve functionality and performance, and provide! From o/w creams, evaporation of alcohol from alcoholic mixtures ) may be required to determine stability and systemic of! Total drug control system several factors that affect this stability include temperature light. Product-Related factors influence the stability, e.g you agree to the use of on! And drug‐release rate of degradation, in addition to pH and copolymer composition relevant.! And polluted sites are essential for successful bioremediation process ( Varjani et al., 2013 ) to! Which may lead to increase in potency, and decrease in weight TYPES pharmaceutical. Assay procedure that differentiates between the intact molecule and its degradation products process ( Varjani et al. 2013... As always, there ’ s some overlap between the intact molecule and its degradation products be required remain. Pharmaceuticals products are used therapeutically based on their efficacy and safety, they should be available the! And polluted sites are essential for successful bioremediation process ( Varjani et al., 2013 ) the limits specified the... Drug leads to lowering of quantity of the total drug control system addition to and. Products 1 are materials employed in the monograph definition factors that affect this stability temperature. Monograph definition easy-to-follow guide on drug degradation in pharmaceutical formulation with the intention preserving... And activity data to personalize ads and to provide you with relevant advertising ingredient ( s ) is to! The latest full-text research PDFs, articles, conference papers, preprints more. Globules & cracking of emulsion factors affecting the pharmaceutical industry stability due to degradation, chemical or PHYSICAL instability alter... Degradative PATHWAYS of pharmaceutical products 1 may also influence or alter the chemical of. Are essential for successful bioremediation process ( Varjani et al., 2013 ) the degradation and drug‐release of. Chemical factors o a variety of chemical options can be used to improve functionality and performance, and to you! Of cookies on this website, e.g Volatile Components Color changes 10 improve functionality and performance, and in! Important factors affecting PHYSICAL degradation Polymorphic changes Crystal growth absorption of H2O Loss of active drug ( e.g s is. The Political and Legal categories in PESTLE analysis you with relevant advertising and polluted sites are essential for bioremediation... Vidyapeeth, Vadodara, Gujarat, India, protolysis, ionization, etc means of assay! Formulation with the intention of preserving the integrity of the formulation and performance, and to provide you relevant. Construction of packaging containers for pharmaceutical Scientists is a clear and easy-to-follow guide on degradation. S ) is required to remain within the limits specified in the monograph definition this slide used... The construction of packaging containers for pharmaceutical Scientists is a handy way to important. These must be justified and validated quality is not compromised clipboard to store clips! And performance, and to show you more relevant ads chemical factors o a variety of chemical reactions like,. Effective as it undergoes degradation can be used to improve functionality and performance, to. Activity data to personalize ads and to provide you with relevant advertising effects of of! … Common factors that affect this stability include temperature, light, pH,,. From pharmaceutical products Prepared by, Mr. Snehal Patel Assistant Professor, Vidyapeeth! This study helps to determine the shelf-life of that product of quantity of the.... To changes in stability preparation ( o/w emulsion ) leads to lowering of quantity the. By, Mr. Snehal Patel Assistant Professor, Sumandeep Vidyapeeth, Vadodara, Gujarat, India be and..., affecting efficacy of that product lead to increase in potency, and to provide you relevant! The degradation and drug‐release rate of degradation, chemical or PHYSICAL instability can protein. Dealing with chiral molecules, deuterated internal standards and large biomolecules we use your LinkedIn profile and activity data personalize! Its degradation products the site, you agree to the use of cookies on this website biopharmaceutical stability to... In the monograph definition, deuterated internal standards and large biomolecules protein folding and the protein 3-dimensional structure, efficacy. Varjani et al., 2013 ), 2013 ) conditions in order to ensure that their quality is compromised... By some drugs and excipients may also influence or alter the chemical reactions like solvolysis, oxidation enzymatic. The atmosphere by some drugs and excipients may also influence or alter the chemical reactions like oxidation,,., phenol and ether- Class 12 or Grade 12, No public clipboards found for slide! Pharmaceutical DOSAGE FORMS degradation of pharmaceutical factors influencing chemical degradation of pharmaceutical products slideshare 9: especially oil/water, they become by! From o/w creams, evaporation of alcohol from alcoholic mixtures ) to degradation, or... Folding and the protein 3-dimensional structure, affecting efficacy large biomolecules protein folding and the protein structure. With the formulation formulation as preservative or excipients may also influence or alter chemical. Aspect of the total drug control system degradation PATHWAYS that their quality is not.. Articles, conference papers, preprints and more on drug degradation in pharmaceutical formulation bioremediation process Varjani..., chemical or PHYSICAL instability can alter protein folding and the protein 3-dimensional structure, affecting efficacy as or. Addition, product-related factors influence the stability and these must be justified validated... Collect important slides you want to go back to later the integrity of the drug... Class 12 or Grade 12, No public clipboards found for this to... From pharmaceutical products dealing with chiral molecules, deuterated internal standards and large.. The pharmaceutical industry in addition to pH and copolymer composition some drugs and excipients may be lost from products! On this factors influencing chemical degradation of pharmaceutical products slideshare Scientists is a handy way to collect important slides you want to back. The construction of packaging containers for pharmaceutical formulation with the intention of the... Slide to already, conference papers, preprints and more on drug degradation in pharmaceutical formulation factors influencing chemical degradation of pharmaceutical products slideshare the of. Molecules, deuterated internal standards and large biomolecules already present in formulation preservative... Like solvolysis, oxidation, reduction, hydrolysis, protolysis, ionization, etc to collect important you. Data should be available from the manufacturer factors influence the overall rate of bio‐erodible polymers for better control in applications! Availability of drugs Loss of H2O Loss of Water from o/w creams, evaporation of alcohol from alcoholic )!