UPSC Drug Inspector flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

6-APA core

6-Aminopenicillanic acid is the bicyclic beta-lactam core of penicillins; acylation of its amino group yields semisynthetic penicillins such as ampicillin and amoxicillin.

Henderson-Hasselbalch equation

Relates pH, pKa and ionisation: for weak acids pH = pKa + log([A-]/[HA]); for weak bases pH = pKa + log([B]/[BH+]). Un-ionised drug crosses lipid membranes more readily.

Noyes-Whitney equation

Dissolution rate dC/dt = k·A·(Cs − C)/h. It states that rate rises with surface area A, solubility Cs and concentration gradient, and falls with diffusion layer thickness h.

Higuchi release model

Describes diffusion-controlled release from a matrix: Q = kH·t^0.5, so cumulative drug released is proportional to the square root of time.

HLB system

Hydrophilic-lipophilic balance scale from 0 to 20. Values 3–6 favour w/o emulsions, 8–18 favour o/w emulsions; polysorbates are hydrophilic and sorbitan esters lipophilic.

Competitive antagonism

Reversible antagonist competes with agonist at the same receptor, shifting the dose-response curve right without reducing Emax. High agonist concentrations can overcome the block.

N-acetylcysteine antidote

Replenishes glutathione and conjugates NAPQI in paracetamol overdose. Most effective when given within 8–10 hours of ingestion; later dosing risks hepatic failure.

Therapeutic index

Ratio of toxic dose to effective dose, usually TD50/ED50. A narrow index (digoxin, lithium, warfarin) means small dose changes cause toxicity, so monitoring is required.

Keller-Kiliani test

Chemical test for cardiac glycosides: ferric chloride in glacial acetic acid layered under sulphuric acid gives a reddish-brown ring, indicating deoxy sugars such as digitoxose.

Sennosides

Anthraquinone glycosides from senna leaf and pod. Colonic bacteria hydrolyse them to active anthrones that stimulate peristalsis, producing a laxative effect.

Beer-Lambert law

Absorbance A = εbc, where ε is molar absorptivity, b path length and c concentration. Absorbance is directly proportional to concentration over the linear range.

LOD and LOQ

Detection limit is 3.3σ/S and quantitation limit is 10σ/S, where σ is the standard deviation of the response and S the calibration slope.

System suitability resolution

Chromatographic resolution R = 2(tR2 − tR1)/(w1 + w2). A value of at least 2.0 is generally required before an HPLC assay is accepted.

Schedule M

Part of the Drugs and Cosmetics Rules, 1945, prescribing Good Manufacturing Practices and premises, plant and quality requirements for pharmaceutical manufacture in India.

Schedule H1 drugs

A sub-list of prescription drugs including certain antibiotics, anti-tuberculosis and psychotropic drugs. Sale requires a separate register with prescriber details retained for three years.

Central Drugs Laboratory

Statutory laboratory at Kolkata under the Drugs and Cosmetics Act. It performs appellate testing, standard-setting and analysis referred by courts and licensing authorities.

D-value

Decimal reduction time: the time at a given temperature to reduce a microbial population by 90%, or one log10 cycle. Used to design sterilisation cycles.

F0 value

Equivalent exposure time at 121 °C with z = 10 °C. Calculated as F0 = Σ10^((T−121)/z)·Δt; a minimum of 12 minutes is used for terminal moist-heat sterilisation.

Bacterial endotoxin test

Limulus amoebocyte lysate assay detects pyrogenic lipopolysaccharide from gram-negative bacteria. The endotoxin limit for parenterals is K/M, with K = 5 EU/kg/h.

Michaelis-Menten kinetics

v = Vmax[S]/(Km + [S]). Km is the substrate concentration giving half maximal velocity and reflects enzyme affinity; a lower Km means higher affinity.

Cockcroft-Gault equation

Estimates creatinine clearance: CrCl = (140 − age) × weight/(72 × serum creatinine), multiplied by 0.85 for females. Used to adjust renally cleared drug doses.

Therapeutic drug monitoring

Measurement of plasma drug concentration to individualise dosing for narrow-therapeutic-index drugs such as digoxin, lithium, phenytoin, vancomycin and cyclosporine.

Stealth liposomes

Phospholipid vesicles coated with polyethylene glycol, which reduces recognition by the reticuloendothelial system and prolongs circulation half-life for passive tumour targeting.

Osmotic pump

Controlled-release device with a semipermeable membrane and laser-drilled orifice. Water influx drives drug solution out at a constant zero-order rate independent of gastrointestinal pH.

Monoclonal antibody nomenclature

Suffix -mab denotes a monoclonal antibody; -ximab is chimeric, -zumab humanised and -mumab fully human, indicating decreasing murine content and immunogenicity.

Biosimilar

A follow-on biologic approved after the innovator patent expires. It is highly similar but not identical, requiring comparability, quality and limited clinical data.

Avogadro's number

6.022 × 10^23 entities per mole. It links mass in grams of a substance to the number of molecules, underpinning molarity and stoichiometric calculations.

Molarity

Concentration expressed as moles of solute per litre of solution. Normality equals gram equivalents per litre; molarity equals normality divided by the number of equivalents per mole.

CDSCO

Central Drugs Standard Control Organisation, India's national drug regulator under the Directorate General of Health Services, handling new drug approvals and licensing coordination.

NPPA

National Pharmaceutical Pricing Authority fixes and revises ceiling prices of scheduled formulations under the Drugs Prices Control Order and monitors overcharging by manufacturers.

Enalapril prodrug

Enalapril is an ester prodrug hydrolysed in the liver to enalaprilat, the active angiotensin-converting enzyme inhibitor. The prodrug improves oral bioavailability.

Sterility assurance level

The probability of a single viable microorganism surviving sterilisation; for terminally sterilised products the accepted SAL is 10^-6, meaning one in a million units non-sterile.