Notes in Russu Drug Stability and Chemical Kinetics Pt.1

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Published	10/29/2023	Drug Stability Slide 2The {{c1::extent}} to which a drug substance (API) or product (final marketed dosage form) retains, within specified limits and …
Published	10/29/2023	Facets of Drug Stbaility{{c1::Chemical}} – {{c2::integrity}} of API and excipients vs {{c2::degradation}} products{{c1::Physical}} – {{c2::intact dosa…
Published	10/29/2023	Example Instabilities Slide 5
Published	10/29/2023	Why is Drug Stablility Important? Slide 6 (important)Change in {{c1::API content}} – higher or lowerChange in {{c1::excipient content}} – higher or lo…
Published	10/29/2023	Factors that Affect Drug Stability Slide 7{{c1::environment}}{{c2::temperature}}, {{c2::humidity}}, {{c2::oxygen}}, {{c2::light}}{{c1::chemical}}-base…
Published	10/29/2023	Example of Environmental Stability Sldie 8Clindamycin hydrochloride solution precipitated when left on a cold counter overnight{{c1::Temperature}} aff…
Published	10/29/2023	Chemical Instability - Ritonavir Example Slide 9{{c1::Polymorph}} impurity (chemical-level) caused inadequate dissolutionfrom soft-gel dosage form
Published	10/29/2023	Chemical Instability - Tetracycline Example Slide 10patient had a bunch of symptoms, consistent with {{c1::Fanconi}} syndromepateitn revealed that&nbs…
Published	10/29/2023	Chemical Degredation Reactions Slide 13{{c1::Hydrolysis}} – {{c2::ester}}, {{c2::lactone}}, {{c2::amide}}, {{c2::lactam}}, {{c2::imide}}{{c1::Oxidatio…
Published	10/29/2023	Functional Groups Susceptible to Hydrolysis Slide 15{{c1::Esters}}, {{c1::Lactones}}{{c1::Carbamates}}{{c2::Amides}}, {{c2::Imides}}{{c2::Lactams}}
Published	10/29/2023	Drugs that are Esters, and their Hydrolysis Products Slide 18(i chose the common ones){{c1::Cocaine}} --> {{c2::Benzoylecagonine}}{{c1::Ethylphenid…
Published	10/29/2023	Examples of Amide, Imide, and Lactam Drugs Slide 19{{c1::Actiq}}{{c1::Melatonin}}{{c1::Ambien}}{{c2::Acetaminophen}}{{c2::Lidoderm}}{{c2::Lenalidomide…
Published	10/29/2023	Hydrolysis Key Points Slide 22**Most common cause of {{c1::degradation}} in aqueous systems.{{c2::Esters}}, {{c2::lactone}}, {{c2::amides}}, {{c2::lac…
Published	10/29/2023	Oxidative Degredation Slide 23Removal of {{c1::electrons}} or addition of {{c1::oxygen atoms}}.Susceptible groups include {{c1::electron rich aromatic…
Published	10/29/2023	Oxidation can Occur at {{c1::Allylic}} and {{c1::Benzylic}} Sites
Published	10/29/2023	Examples of Pharmaceutical Anti-Oxidants (I put 5){{c1::BHA}}{{c1::BHT}}{{c1::Propyl Gallate}}{{c2::Ascorbic Acid}} ({{c2::Vitamin C}}){{c2::Vitamin E…
Published	10/29/2023	Oxidation Key Points{{c1::Second most common}} cause of drug degradation.Susceptible drugs contain {{c1::pi-bonds}} such as {{c1::alkenes}}, {{c1::pol…
Published	10/29/2023	Isomerization Slide 31Interconversion of isomers.Geometric isomerization (3){{c1::Cis/trans}}, {{c1::E/Z}}, {{c1::double bond migration.}}Stereochemic…
Published	10/29/2023	Example of Isomerization is {{c1::Tetracycline}} Slide 34
Published	10/29/2023	How Does Light lead to Drug Degredation? Slide 35light can {{c1::excite pi-bonds}}, promoting drug degredation, including isomerization
Published	10/29/2023	Isomerization and Photo-lability Key PointsFor acid/base processes like {{c1::tautomerization}} of chiral ketones, esters and enones, or {{c1::dehydra…
Published	10/29/2023	Polymerization Slide 44{{c1::Two}} or more {{c1::identical}} drug molecules combine to form a new larger molecule with a {{c1::repeating}} unit.Molecu…
Published	10/29/2023	Other Key Points Slide 46Drug stability is important for the {{c1::integrity}} of the API as well as the finished drug product.Knowledge of a drug's {…
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