High-yield, original notes for the SPLE Pharmaceutical Sciences domain (35% of the exam, SCFHS blueprint Area 2.0). Every fact below carries its primary source. No sign-up, no cost.
SCFHS SPLE Applicant Guide SPLE0622, Appendix B Area 2.0 Pharmaceutical Sciences (35%): 2.4 pharmaceutics and biopharmaceutics, 2.5 pharmacokinetics, 2.6 sterile and nonsterile compounding including pharmaceutical calculations (Appendix B, guide pp.15-16).
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Blueprint 2.5. The core first-order relationships tested by the calculation questions.
| Concept | Formula or rule | How it is used | Source |
|---|---|---|---|
| Elimination half-life | Half-life equals 0.693 divided by the elimination rate constant | After each half-life the amount halves: one half, one quarter, one eighth after three half-lives | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-01 · Report a mistake |
| Loading dose | Loading dose equals volume of distribution times target concentration divided by bioavailability | Used when the target level is needed quickly instead of waiting for accumulation | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-02 · Report a mistake |
| Infusion steady state | Infusion rate equals clearance times target steady-state concentration | Steady state is approached after about four to five half-lives without a loading dose | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-03 · Report a mistake |
| Total clearance | After an intravenous dose, clearance equals dose divided by area under the curve | Combines all elimination routes into one flow-equivalent value | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-04 · Report a mistake |
| Volume of distribution | Volume equals amount in the body divided by plasma concentration | A large value signals extensive tissue distribution, not a real anatomical volume | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-05 · Report a mistake |
| Saturable metabolism | Near metabolic capacity, small dose increases cause disproportionately large level rises | Phenytoin is the classic example; check levels after small dose changes | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-06 · Report a mistake |
| Organ clearance limits | Renal loss lowers renally cleared drug clearance; high hepatic extraction clearance follows liver blood flow | Reduce dose or extend interval in renal failure; expect flow-limited changes after hepatic blood flow falls | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-07 · Report a mistake |
| Protein binding | Low albumin raises the free fraction of highly bound drugs | Interpret free levels where available; a low total level can still be active or toxic | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-pk-08 · Report a mistake |
Practise the Pharmaceutical Sciences quiz · Report a mistake in this section
Blueprint 2.4 and 2.5.2. Why a dosage form does or does not deliver drug to the circulation.
| Concept | Principle | Practical consequence | Source |
|---|---|---|---|
| Bioequivalence interval | The 90 percent confidence interval for area under the curve and peak concentration ratios must lie within 80.00 to 125.00 percent | The standard acceptance test for a generic oral product against its reference | FDA, Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations, 2003 Fact note-ps-ba-01 · Report a mistake |
| BCS Class II behaviour | Low solubility with high permeability makes dissolution the rate-limiting step | Improve wetting, particle size, or salt form before expecting faster absorption | FDA, Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, 2017 Fact note-ps-ba-02 · Report a mistake |
| Dissolution rate | Smaller particles, a suitable salt, or a more soluble polymorph raise dissolution rate | Solid-state and particle choices change onset even when the dose is identical | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-ba-03 · Report a mistake |
| pH and ionisation | A weak acid is mainly unionised below its pKa and crosses lipid membranes in that form | Explains site and timing differences in oral absorption | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-ba-04 · Report a mistake |
| Food and first-pass effects | High-fat food delays gastric emptying and the peak; sublingual dosing partly bypasses first-pass metabolism | Separate timing advice from extent-of-absorption advice when counselling | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-ba-05 · Report a mistake |
| Absolute bioavailability | Oral area under the curve divided by intravenous area under the curve at equal doses | Quantifies the fraction reaching the systemic circulation unchanged | Shargel, Wu-Pong and Yu, Applied Biopharmaceutics and Pharmacokinetics, 7th edition, McGraw-Hill — pharmacokinetics chapters, 2016 Fact note-ps-ba-06 · Report a mistake |
Practise the Pharmaceutical Sciences quiz · Report a mistake in this section
Blueprint 2.4.1 to 2.4.3. Form, release design, and the counselling or quality test that follows.
| Dosage form or test | Key principle | Pharmacy action | Source |
|---|---|---|---|
| Extended-release tablets | Crushing destroys the controlled-release mechanism and risks dose dumping | Counsel swallowing whole; the cited label states the whole or half tablet must not be crushed or chewed | DailyMed — METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE label, 2.4 Administration Fact note-ps-df-01 · Report a mistake |
| Gastro-resistant tablets | The coat resists stomach acid and dissolves at intestinal pH | Protects acid-labile drugs and releases them in the small intestine | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-df-02 · Report a mistake |
| Suspensions and emulsions | Flocculated suspensions redisperse easily; creaming is reversible but coalescence is not | Shake suspensions before use; discard an emulsion that has cracked | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-df-03 · Report a mistake |
| Suppository bases | Fatty bases melt at body temperature; water-soluble bases dissolve in rectal fluid | Choose and store the base for its intended release behaviour | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-df-04 · Report a mistake |
| Patches and inhalers | Patches need intact skin and site rotation; a holding chamber reduces throat deposition | Heat and broken skin raise patch absorption; a chamber helps poor inhaler coordination | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-df-05 · Report a mistake |
| Friability testing | A rotating drum test measures tablet weight loss from abrasion and chipping | Excessive loss is a mechanical strength failure at quality control | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-df-06 · Report a mistake |
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Blueprint 2.6. USP chapters for sterile, nonsterile, and hazardous compounding and dating.
| Standard | Requirement | Why it matters | Source |
|---|---|---|---|
| USP <797> sterile compounding | Critical sites need ISO Class 5 air in the primary engineering control | Cleaner than the ISO Class 7 buffer area around it | USP <797> Pharmaceutical Compounding — Sterile Preparations, United States Pharmacopeia, revised chapter effective 1 November 2023, 2023 Fact note-ps-cx-01 · Report a mistake |
| USP <795> nonsterile dating | A nonpreserved aqueous preparation is limited to 14 days refrigerated | Preserved aqueous, nonaqueous, and solid preparations carry longer chapter limits | USP <795> Pharmaceutical Compounding — Nonsterile Preparations, United States Pharmacopeia, revised chapter effective 1 November 2023, 2023 Fact note-ps-cx-02 · Report a mistake |
| USP <800> hazardous compounding | Sterile hazardous compounding needs negative pressure and external venting with protective equipment | Contains hazardous contamination and protects staff | USP <800> Hazardous Drugs — Handling in Healthcare Settings, United States Pharmacopeia, 2020 Fact note-ps-cx-03 · Report a mistake |
| Beyond-use dating | The pharmacy assigns a beyond-use date after compounding or repackaging | It is distinct from the manufacturer expiry date on the unopened product | USP <795> Pharmaceutical Compounding — Nonsterile Preparations, United States Pharmacopeia, revised chapter effective 1 November 2023, 2023 Fact note-ps-cx-04 · Report a mistake |
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Blueprint 2.4.4. Chemical degradation and physical instability, and how storage controls them.
| Factor | Effect | Pharmacy action | Source |
|---|---|---|---|
| First-order shelf life | Time to 90 percent remaining equals 0.105 divided by the rate constant | Defines the modelled shelf life endpoint in stability studies | ICH Harmonised Guideline Q1A(R2), Stability Testing of New Drug Substances and Products, 2003 Fact note-ps-st-01 · Report a mistake |
| Hydrolysis | Reaction with water breaks down susceptible drugs in aqueous products | Use tight containers and moisture protection to slow potency loss | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-st-02 · Report a mistake |
| Temperature effect | Reaction rates rise with temperature under the Arrhenius relationship | Controlled cool storage slows degradation; heat accelerates it | ICH Harmonised Guideline Q1A(R2), Stability Testing of New Drug Substances and Products, 2003 Fact note-ps-st-03 · Report a mistake |
| Photodegradation | Light breaks down photosensitive medicines | Dispense and store in light-resistant amber containers | ICH Harmonised Guideline Q1A(R2), Stability Testing of New Drug Substances and Products, 2003 Fact note-ps-st-04 · Report a mistake |
| Emulsion cracking | Freezing can coalesce droplets into free oil that shaking cannot recombine | Discard a cracked emulsion; do not shake, warm, or dilute it back into use | Aulton and Taylor, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 5th edition, Elsevier — dosage form design and stability chapters, 2018 Fact note-ps-st-05 · Report a mistake |
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Blueprint 2.6.3. Three worked examples. Do each step yourself before reading the answer.
Source: Ansel and Stockton, Pharmaceutical Calculations, 15th edition, Wolters Kluwer — percentage, alligation and flow-rate chapters, 2017 · Fact note-ps-calc-01 · Report a mistake
Source: Ansel and Stockton, Pharmaceutical Calculations, 15th edition, Wolters Kluwer — percentage, alligation and flow-rate chapters, 2017 · Fact note-ps-calc-02 · Report a mistake
Source: Ansel and Stockton, Pharmaceutical Calculations, 15th edition, Wolters Kluwer — percentage, alligation and flow-rate chapters, 2017 · Fact note-ps-calc-03 · Report a mistake
Practise the Pharmaceutical Sciences quiz · Report a mistake in this section
Sources checked 2026-11-03. These notes are independent practice material, not official SCFHS material and not a substitute for the current drug label, textbook, or USP chapter. If a fact here disagrees with a current source, the source wins — please report it.