Medicinal Chemistry Flashcards
What are the quality critical attributes for a parental product?
Sterility
Endotoxin free
Particulate Free
PH - affects solubility and will be different dependent on the site of injection
What is Pharmacovigilance and describe the PV system?
PV also know as drug safety is the science relating to the collection, detection, assessment and monitoring of adverse effects with pharmaceuticals
Eudralex volume 9
MAH responsible for having a PV system in place
PSMF
Individual case safety reports
Complaints / Adverse Events
Medical Risk Assessments
Involved in CTA and MA approvals
What is in a PSMF?
Describes the PV system
Information on the QPPV
Organisational Structure of MA holder
Source of Safety Data
Computerised systems and databases
PVV process
PVV performance
Quality System
Annex- list of products, policies, Tech Agreements and Audits
What is the role of the QPPV?
Responsible for the oversight of the PV system
Responsible for the PSMF and individual case study reports
How do the following drugs work:-
Beta Blockers
Diuretics
Ace inhibitors
Digoxin
Reduce heart rate and force ventricular contraction- block adrenaline and nor adrenaline - treat Angina
Promote renal excretion of salt water by blocking tubular re-absorption. Resultant loss of fluid
Dilate blood vessels and reduce vascular resistance- inhibit ACE which converts AngI to AngII
Digoxin is a cardiac glycoside it is used for heart failure / arrhythmias has a narrow therapeutic index
Explain First Pass Metabolism
Phenomenon of drug metabolism whereby the concentration of a drug when administered orally is greatly reduced before reaching systemic circulation.
Drug absorbed by digestive system- enters hepatic portal system and carried to the liver via the portal vein. The liver will metabolise many drugs before releasing into circulation resulting in reduced bioavailability
What is the difference between Pharmaceutical equivalence vs Bioequivalence?
- PE - same active substance, dosage form and meet comparable standards
- BE - if product demonstrates equivalence and similar bioavailabilities after administration
How do the following work:-
a) Analgesics
b) Anti Depressants
c) Sympatominetic
d) Corticosteroids
a) non-steroidal anti-inflammatory for pain relief. Reversibly inhibit cyclo-oxgenase enzymes inhibiting prostaglandin synthesis
b) Inhibit reuptake of neurotransmitters through selective receptors increasing concentration of specific neurotransmitters in brain for selective serotonin re-uptake.
c) mimic responses due to stimulation of sympathetic nerves eg. Asthma relaxes bronchial smooth muscle.
d) used as anti-inflammatory- bind to intercellular receptors to modulate gene transcription in inflammatory genes.
Route of metabolism of Zoladex?
Combination of hepatic and urinary excretion- 90% urine 10% liver.
What aspects of your drug could a change in particle size impact?
Dissolution
Bioavailability
Flow
Blending Characteristics
Texture
Stability
Performance
What is Pharmacology, Pharmacokinetics and Pharmacodynamics?
Pharmacology- study effect of drug on living organisms
Pharmacokinetics- effects of body on drug (ADME)
Pharmacodynamics- effect of drug on body.
Name some common therapeutic areas and treatments?
Nervous System - Analgesics, Anti Depressants
Respiratory- corticosteroids, sympatominetic
Cardiovascular- Beta Blockers, ACE Inhibitors
Endocrine - Diabetes
Infection- Antibiotics
Renal - Diuretics
What drugs will you be concerned about introducing to your facility?
Celphasporin
Hormones
B- Lactam
Cytotoxic
Penicillins
What effects to the following receptors have?
a) Agonist
b) Antagonist
c) Inverse Agonist
a) Stimulates receptors
b) Drug blocks receptors
c) Reduces activity of receptors
What are the Quality Critical aspects of Zoladex?
Average Mass / Uniformity of Mass
Assay - Goserelin
Water Content
Impurities ( Acetic Acid)
Related Substances
Uniformity of Content
Dissolution
Sterility
Endotoxin
Particulate Free
