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Tablet Manufacture Assessment Spring 2026
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Flashcards in this deck (72)

Recherche en cours...

  • Name common tablet excipient categories used in tablet formulations.

    • Binder
    • Filler-Diluent
    • Coating
    • Disintegrant
    • Lubricant / Glidant
    • Solubilizer
    excipients tablets

  • What are three standard physical tests used to evaluate tablets?

    • Friability
    • Hardness
    • Disintegration

    Tablet hardness tester

    evaluation quality

  • What is a tablet in pharmaceutics?

    • A mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid.
    tablets definition

  • What proportion of prescriptions are solid dosage forms, and what proportion of those are compressed tablets?

    • About two-thirds of all prescriptions are dispensed as solid dosage forms
    • Half of these solid dosage forms are compressed tablets
    pharmaceutics tablets

  • What are the two basic physical types of tablets?

    • Molded
    • Compressed
    tablets types

  • Name common tablet formulations, coatings, or release forms.

    • Immediate release
    • Multiple compressed
    • Film coated
    • Gelatin coated
    • Enteric coated
    • Sugar coated
    • Buccal/Sublingual
    • Chewable
    • Effervescent
    • Lozenge
    • Melt Extrusion
    • Delayed/Extended/Controlled release
    formulations coatings release

  • What is an excipient in a tablet formulation?

    • Excipient: 'A largely inert substance that is added to a drug formulation to improve administration or absorption.' (FDA: pharmaceutical necessity)
    excipients pharmaceutics

  • Name major tablet excipient types and their primary function.

    • Binder: forms granules and improves tablet compaction
    • Disintegrant: speeds disintegration and dissolution
    • Lubricant: reduces adhesion to tooling
    • Filler (Diluent): increases volume
    • Glidant: improves powder flow
    • Coating: protects from moisture; can control dissolution
    • Solubilizer: improves drug solubility
    excipients functions

  • Name the main tablet routes of administration listed.

    • Oral
    • Sublingual
    • Buccal
    • Vaginal
    • Rectal
    pharmacology routes

  • What are the main sequential steps of tablet manufacture?

    • Dispensing (weighing and measuring)
    • Size reduction
    • Blending and mixing
    • Granulation (wet or dry) and dryin
    • Compression and Tablet Dedusting
    • Coating if applicable
    • Packaging
    manufacturing tablets

  • After granulation (wet or dry) and dryin, what is the next tablet manufacturing step?

    • Compression and Tablet Dedusting
    compression tablets

  • What tablet manufacturing process is indicated by the heading in the figure?

    • Dry granulation
    granulation manufacturing

  • What are the key requirements for direct compression of a tablet powder blend?

    • Tableting without prior granulation
    • API sensitive to heat/moisture: yes
    • Requires appropriate compressibility, good flowability, and stable homogeneity (no demixing)
    • Suitable powder blend achievable via excipient selection
    granulation direct_compression

  • How do wet granulation and dry granulation differ regarding API sensitivity and excipient selection?

    • Wet granulation: API not sensitive to heat/moisture; suitable powder blend through excipient selection not required
    • Dry granulation: API sensitive to heat/moisture; suitable powder blend achievable via excipient selection
    granulation wet_granulation dry_granulation

  • What are the main advantages of direct compression for tablet manufacturing?

    • Continuous manufacturing (CM) suitable
    • Highly efficient process
    • Reduced strain on API (suitable for sensitive APIs)
    • Less time- and resource-intensive
    • Reduced number of process steps
    • Solvent-free
    granulation directcompression manufacturing

  • How do dry and wet granulation differ in methods and key benefits?

    • Dry granulation: CM suitable; solvent-free
    • Wet granulation: Strong binding; improves compressibility; broad application range; methods include high shear (HS), twin screw (TS), fluid bed (FB); HS and FB widely established in large-scale manufacturing; CM suitable (TS, FB)
    granulation drygranulation wetgranulation

  • What is a primary disadvantage of using direct compression (DC) or dry granulation for tablet manufacture?

    • May require DC grades of excipients, which can increase raw material prices
    granulation cost

  • What are the main disadvantages of wet granulation listed for tablet manufacture?

    • Use of organic solvents
    • High equipment footprint and operating costs due to mandatory drying
    • Residual solvent risk
    granulation wet

  • Which flow properties are evaluated for pharmaceutical powders and granules?

    • Angle of repose
    • Bulk density
    • Tapped density
    • Carr's compressibility index
    • Hausner ratios
    pharmaceutics flow

  • Name three main parts visible in the tablet press mechanism.

    • Top punch
    • Bottom punch
    • Powder
    tablet compression mechanism

  • Why do tablets larger than 800 mg present a problem?

    • Tablets larger than 800 mg are increasingly difficult to swallow
    tablets swallowability

  • What content-uniformity challenge arises with low API loading in tablets?

    • Content uniformity becomes challenging when the API is less than approximately 5% of the tablet
    tablets formulation

  • What does the term 'depth of bisect' refer to in tablet bisecting?

    Splitting

    tablets bisect

  • Name a tablet attribute listed as relevant to tablet bisect.

    • Tablet size
    tablets size

  • What are the United States Pharmacopoeia (USP) requirements for oral drug products?

    • Description (appearance)
    • Identification
    • Strength (assay)
    • Impurities (organic, inorganic, residual solvents)
    usp quality

  • Which specific USP evaluation tests are listed for tablets?

    • Dissolution <711> & <724>
    • Volatile content (Loss on drying) <731>
    • Disintegration <701>
    • Tablet friability <1216>
    • Breaking force <1217>
    • Uniformity <905>
    tablets tests

  • What appearance features are required or evaluated for pharmaceutical tablets?

    • Printed/embossed characters required by FDA
    • Checked for discoloration, mottling, specks, chips, cracks
    appearance quality

  • What are key considerations about tablet odor during analysis?

    • USP 23/NF 18 discusses taste & odor
    • Odor may aid identification of causative agent
    • Analyst safety is a concern with potent/volatile drugs
    odor safety

  • What are common tablet defects listed in the notes?

    • Picking & sticking
    • Capping & lamination
    • Orange peel
    • Erosion
    • Roughness
    • Bridging
    pharmacy tablet_defects

  • Match each tablet defect to its stated cause.

    • Picking & sticking: occurs during compression
    • Capping & lamination: excessive compression force
    • Orange peel / Roughness: excessive drying during film coating
    • Erosion: soft tablets
    • Bridging: insufficient flow during film coating
    pharmacy causes

  • What is the current USP <905> weight variation threshold for applying the test?

    Applied when the active is 25 mg or more and comprises 25% or more by weight of the dosage form.

    usp905 weightvariation

  • What sample size and procedure does USP <905> specify for weight variation testing?

    Select not less than 30 dosage units; weigh 10 tablets and use assay results to calculate active content assuming homogeneous distribution.

    usp905 sampling

  • What is the difference between weight uniformity and content uniformity for tablets?

    • Weight uniformity: assay individual tablet weight
    • Content uniformity: assay quantity of drug in a single dosage unit
    quality uniformity

  • What was the overall percentage of half-tablets that fell outside the proxy USP specification for drug content in the tablet-splitting study?

    • 23.9% of 180 half-tablets differed from sample mean by a percentage outside the proxy USP specification
    tablet_splitting statistics

  • What are tablet thickness specifications typically based on?

    • Set specifications based on development history
    • Regulatory filing criteria not generally required
    thickness specifications

  • What are the main ramifications of tablet thickness variability?

    • Weight and compressibility variability
    • Altered disintegration/dissolution due to porosity changes
    • Packaging issues, especially unit dose cavities and re-work for additional coating
    thickness quality

  • What is tablet friability and what commonly causes it?

    • Resistance to abrasion of tablets
    • Caused by manufacturing, transportation, and patient handling
    pharmaceutics friability

  • What is the formula for friability percentage and what do the variables mean?

    • \(F (\%) = (W_o - W) \times 100\)
    • W_o: original weight
    • W: weight after the experiment
    • Tablets are tumbled in a rotating drum during testing
    pharmaceutics friability testing

  • What is 'breaking force' for a solid tablet?

    The resistance of a solid to local permanent deformation.

    breaking-force definition

  • What does the 'Diametral Compression Test' (crushing strength) cause and what testing limitation is noted?

    • The compact fails in tension during the diametral compression test
    • Early testing methods showed strain-rate dependence causing variability
    • Not to be confused with shear failure
    diametral-compression testing failure-modes

  • What two subtopics are listed under 'Tablet Hardness'?

    • Hardness vs. Pmax
    • Uniformity of Void [Density] Distribution
    tablet hardness

  • What three image types accompany the 'Tablet Hardness' section?

    • Line graph of tensile strength vs. an unspecified parameter
    • Contour plots of void distribution for single and double ended compaction
    • Close-up photo of a hardness tester with a dial indicator
    tablet images

  • What is the sequence of physical stages in the dissolution process of a solid oral dosage form?

    • Tablet or capsule
    • Granules or aggregates
    • Fine particles
    • Drug in solution
    • Drug in blood, other fluids, and tissues
    dissolution pharmaceutics

  • What are the final compartments reached by the drug after dissolution from a solid dosage form?

    • Drug in solution
    • Drug in blood, other fluids, and tissues
    dissolution pharmacokinetics

  • What are the two simultaneous processes involved in tablet disintegration?

    • Fluid penetration
    • Particle separation
    disintegration pharmaceutics

  • List the key parameters of the basket-rack assembly used for disintegration testing.

    • 10-mesh No. 23 (0.025-inch) wire cloth
    • Temperature 35°C to 39°C
    • 29 to 32 cycles per minute
    • Six tablets, one per tube
    disintegration testing

  • What is the definition of disintegration for tablets?

    Disintegration is the state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen is a soft mass having no palpably firm core.

    disintegration pharmaceutics

  • What are the acceptable tablet disintegration times for common tablet types?

    • Uncoated: 10–30 min
    • Coated: up to 2 h
    • Sublingual: ≤ 5 min
    • Enteric coated: no disintegration in gastric fluid (1 h); disintegrate in intestinal fluid within specified time
    disintegration tablets

  • What is the primary aim of in vitro dissolution testing?

    To provide a representative prediction of the product's in vivo bioavailability

    dissolution pharmaceutics

  • What are other key purposes of in vitro dissolution testing?

    • Assess lot-to-lot quality
    • Guide development of new formulations
    • Formulate generics of branded products
    • Ensure product quality after formulation or process changes
    dissolution quality

  • What are the four BCS categories and their solubility/permeability characteristics?

    • I: High solubility and high permeability
    • II: Low solubility and high permeability
    • III: High solubility and low permeability
    • IV: Low solubility and low permeability
    bcs pharmacology

  • What does the Biopharmaceutics Classification System (BCS) correlate and why?

    BCS correlates combinations of a drug's solubility (high or low) and its intestinal permeability (high or low) as a possible basis for predicting the likelihood of achieving a successful in vivo-in vitro correlation (IVIVC).

    bcs ivivc

  • What is the Type 2 dissolution apparatus and which dosage forms is it used for?

    • Paddle apparatus
    • Orally disintegrating and chewable tablets, capsules, and suspensions
    dissolution apparatus

  • Which dissolution apparatus types are used for transdermal patches?

    • Type 5: Paddle over disk
    • Type 6: Rotating cylinder
    • Type 7: Reciprocating holder (for non-disintegrating tablets and transdermal patches)
    dissolution transdermal

  • What are the two common USP dissolution apparatus types described and their primary agitation elements?

    • Apparatus 1: rotating basket
    • Apparatus 2: paddle
    dissolution apparatus

  • What are the standard dissolution test conditions for screen material, temperature, and rotation speed range?

    • Screen: 40 mesh, type 316 SS
    • Temperature: 37°C
    • Rotation: 25–150 rpm
    dissolution conditions

  • What are the dissolution requirements for divalproex sodium ER at 3, 9, 12 and 24 hours (500 mg and 250 mg doses)?

    • 3 hours: 10%–30%
    • 9 hours: 35%–55% (500 mg) / 35%–60% (250 mg)
    • 12 hours: 45%–70% (500 mg) / 45%–75% (250 mg)
    • 24 hours: NLT 75%
    dissolution pharmaceutics

  • What in vitro dissolution procedure is specified for divalproex sodium ER tablet testing?

    • Initial stage: 45 minutes in acid stage medium (0.1 N hydrochloric acid)
    • Second stage: replace acid medium with buffer stage medium (pH 5.5 phosphate/SDS/NaOH)
    • 'NLT' means 'Not less than'
    dissolution testing

  • What routine microbiological monitoring targets are mentioned for nonsterile environments?

    • Total count of viable aerobic microorganisms
    • Total combined molds and yeasts
    microbiology monitoring

  • Name specified objectionable microorganisms listed for testing in USP <62> for nonsterile products.

    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Escherichia coli
    • Salmonella enterica (Typhimurium or Abony)
    • Candida albicans
    • Clostridium sporogenes
    microbiology pathogens

  • What is done when microorganisms are detected in pharmaceutical materials or products?

    They typically undergo characterization, which may include identification and strain typing as appropriate.

    microbiology characterization

  • Which specified microorganisms are tested for in nonsterile pharmaceutical products?

    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Escherichia coli
    • Salmonella enterica (serovar Typhimurium or serovar Abony)
    • Candida albicans
    • Clostridium sporogenes
    microbiology testing

  • What is water activity defined as?

    • Effective mole fraction of water
    wateractivity definition

  • What is the approximate absolute water activity limit for microbial growth?

    • Approximately 0.6
    microbiology wateractivity

  • What three factors determine human perception of color?

    • Spectral energy of the illumination
    • Object characteristics
    • Visual sensitivity
    color perception

  • What is the CIE 1931 contribution to colorimetry and which tristimulus values does it define?

    • CIE 1931 standardizes color specification
    • Tristimulus values: X, Y, Z
    cie colorimetry

  • What are the microbial limits and specified organism requirement for aqueous and nonaqueous preparations for oral use?

    • Nonaqueous oral: TAMC \(10^{3}\); TYMC \(10^{2}\); Absence of Escherichia coli (1 g or 1 mL)
    • Aqueous oral: TAMC \(10^{2}\); TYMC \(10^{1}\); Absence of Escherichia coli (1 g or 1 mL)
    microbiology oral

  • What are the microbial limits and specified organism requirements for oromucosal, gingival, cutaneous, and nasal preparations?

    • Oromucosal/gingival: TAMC \(10^{2}\); TYMC \(10^{1}\); Absence of Staphylococcus aureus (1 g or 1 mL) and Pseudomonas aeruginosa (1 g or 1 mL)
    • Cutaneous/nasal: TAMC \(10^{2}\); TYMC \(10^{1}\); Absence of Staphylococcus aureus (1 g or 1 mL)
    microbiology topical

  • What are the permitted microbial limits for auricular, vaginal, transdermal patch, and inhalation routes?

    • Total Aerobic Microbial Count: \(10^{2}\) cfu/g or cfu/mL
    • Total Combined Yeasts/Molds Count: \(10^{1}\) cfu/g or cfu/mL
    microbiology limits

  • Which specified microorganisms must be absent in 1 g or 1 mL for inhalation preparations?

    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Bile-tolerant Gram-negative bacteria
    microbiology inhalation

  • Which quality-control checks must be performed in the pharmacy for final dosage forms?

    • Final dosage form weight verification: ±10% ideal
    • Component weight verification: ±10% ideal
    • Visual verification: appearance, uniformity, pharmaceutical elegance, defects
    • Odor/flavor
    qualitycontrol pharmacy

  • Which analytical tests are indicated as outsourceable to a laboratory?

    • HPLC
    • GC
    • Dissolution
    analytical outsourcing
Notes de cours

Tablet Manufacture & Evaluation — PHAR 5220 (concise study notes)

Definition & importance

  • Tablet: a solid dosage form of API(s) + excipients compressed or molded from powders.
  • Widely used: ~two-thirds of prescriptions are solids; half of those are compressed tablets.

Advantages / Disadvantages (key points)

  • Advantages: convenient, accurate dosing, stable, tastemasking, flexible release (immediate, sustained, enteric).
  • Disadvantages: possible degradation/first-pass metabolism, GI interactions, swallowing difficulty, systemic side effects.

Types of tablets (major categories)

  • Based on manufacture: molded, compressed (direct compression, dry granulation, wet granulation).
  • By function/coating: immediate release, multiple/compressed, film/enteric/sugar coated, buccal/sublingual, chewable, effervescent, lozenge, extended/controlled release.

Core tablet composition — excipients & roles

  • API (active pharmaceutical ingredient).
  • Excipients (typical % ranges & function):
  • Binder (4–6%): forms granules e.g., acacia, PVP, HPMC.
  • Disintegrant (3–6%): promotes breakup, e.g., croscarmellose, crospovidone.
  • Lubricant (0.25–1%): reduces tooling adhesion, e.g., magnesium stearate.
  • Filler/diluent (5–80%): increases tablet bulk, e.g., lactose, microcrystalline cellulose.
  • Glidant (<2%): improves powder flow, e.g., colloidal silicon dioxide.

  • Flavors, colorants, compression enhancers (e.g., microcrystalline cellulose).

  • Takeaway: choose excipients to balance flow, compressibility, disintegration, and stability.

Routes of administration (tablets)

  • Oral, sublingual, buccal, vaginal, rectal — route affects onset, local vs systemic action.

Manufacture: main process steps

  1. Dispensing (weighing)
  2. Size reduction (milling)
  3. Blending/mixing
  4. Granulation (wet or dry) or direct compression
  5. Drying (if wet granulation)
  6. Compression (tablet press)
  7. Coating (optional)
  8. Packaging

Granulation methods — selection summary

  • Direct compression (DC): simplest; solvent-free; needs good-flowing, compressible powders; suited to moisture/heat-sensitive APIs.
  • Dry granulation: roller compaction; solvent-free; used when API sensitive to moisture/heat but requires equipment.

  • Wet granulation: uses binder solution; improves compressibility and blend uniformity; higher equipment and drying cost; risk of residual solvents.

  • Decision basis: API sensitivity to moisture/temperature, powder flow/compressibility, raw material variability, equipment availability.

Powder & granule flow properties (evaluation)

  • Key tests: angle of repose, bulk density, tapped density, Carr's compressibility index, Hausner ratio.
  • These predict fill uniformity and compressibility for tableting.

Tablet compression & tooling

  • Tablet press fills dies with powder/granules and uses top and bottom punches to compress in stages (fill, pres-press, main compression, ejection).
  • Control variables: fill depth, compression force, dwell time, punch/die condition.

A tablet hardness tester is shown.

Alt: Tablet hardness tester image

Tablet shape, size, and splitting

  • Many shapes available; larger tablets (>~800 mg) harder to swallow.
  • Scored tablets allow splitting but can cause content nonuniformity — splitting may produce halves outside USP proxies for content.
  • Match tablet size/shape to dose and patient factors (e.g., geriatric swallowability).

Key evaluation tests & USP standards (overview)

  • General quality attributes: appearance, identification, assay (strength), impurities, dissolution, disintegration, friability, breaking force, uniformity.
  • USP references: e.g., dissolution <711>/<724>, disintegration <701>, friability <1216>, breaking force <1217>, uniformity of dosage units <905>.

Weight variation vs content uniformity

  • Weight uniformity: measure tablet mass; used when formulation is homogeneous and API is a significant portion of tablet weight.
  • Content uniformity: assay individual units for API amount; required when API is potent or low % of tablet weight.
  • Note: Good blend homogeneity makes weight uniformity predictive of content uniformity; splitting undermines uniformity.

Thickness

  • Set during development; affects weight, porosity, disintegration/dissolution, and packaging fit.

Friability

  • Measures resistance to abrasion (manufacture, transport, handling).

  • Use a rotating drum; calculate percent weight loss after test as friability.

  • Formula:

\[F(\%) = \frac{W_o - W}{W_o} \times 100\]

where \(W_o\) is the initial weight and \(W\) is the weight after testing.

Breaking force / Hardness

  • Breaking force (crushing strength): resistance to failure under diametral compression; relates to compaction conditions and formulation.
  • Hardness is strain-rate dependent; use validated instruments and report method details (dwell time, geometry).

Disintegration

  • Two simultaneous processes: fluid penetration (wicking) and particle separation (swelling/wetting).
  • Typical USP conditions: basket-rack at 35–39°C, 29–32 cycles/min; six tablets tested.
  • Typical acceptance times: uncoated ~10–30 min; coated up to 2 h; sublingual ≤5 min; enteric: no gastric disintegration (1 h) but disintegrates in intestinal fluid.

Diagrams showing the processes of wicking and swelling in tablets.

Alt: Wicking and swelling during disintegration

Dissolution — purpose & apparatus

  • Purpose: in vitro predictor of in vivo bioavailability, development tool, batch quality control, and generics equivalence.

The dissolution process of solid dosage forms is represented in a diagram.

Alt: Dissolution process flowchart

  • Common apparatus (USP):
  • Type 1 — Basket (tablets, capsules)
  • Type 2 — Paddle (disintegrating/chewable tablets, capsules)
  • Type 3 — Reciprocating cylinder (tablets, granules)
  • Type 4 — Flow-through cell (all forms)
  • Types 5–7 — specialized (patches, non-disintegrating forms)

The image shows a dissolution apparatus.

Alt: Dissolution apparatus (vessels and paddle/basket)

  • Control variables: medium composition/pH, temperature (usually 37±0.5°C), agitation (rpm), sink conditions, and sample handling.

Biopharmaceutics Classification System (BCS) — quick table

BCS Class Solubility Permeability
I High High
II Low High
III High Low
IV Low Low
  • BCS helps predict IVIVC and guide dissolution testing needs.

Microbiology & water activity

  • Nonsterile products must meet microbial limits (USP <1111>, <62>) and absence of specified pathogens for certain routes.
  • Maintain environmental control, sanitation, and monitoring; control water activity to inhibit microbial growth (microbial growth limit ~aw 0.6).

Diagram shows nonsterile product microbial influences.

Alt: Factors influencing nonsterile product microbiology

Color & appearance

  • Color depends on illumination, materials, and human perception (CIE tristimulus system used for objective color measures).
  • Appearance, embossing/printing, and odor are part of acceptance criteria and identification.

Common tablet defects (what to watch for)

  • Picking & sticking, capping & lamination, twinning, orange peel (coating), erosion, roughness, bridging — mostly linked to poor formulation, moisture control, or process settings.

Quality control & documentation (pharmacy-level vs lab)

  • In pharmacy: weight verification (±10% target), component checks, visual inspection (uniformity, defects), odor/flavor check.
  • Lab tests (outsourced): HPLC assay, GC, dissolution profiling, microbial testing.

Practical tips for exams and labs

  • Know excipient purpose and typical % ranges.
  • Be able to choose a granulation method based on API sensitivity and powder properties.
  • Remember friability formula and USP tests/durations for disintegration/dissolution basics.
  • When asked about QC, separate in-house checks (visual, weight) from lab assays (assay, dissolution, impurities).

References for deeper study: Ansel’s Pharmaceutical Dosage Forms (chapters on tablets), USP compendia sections cited above.