Drug Development & QC

Pharmaceutical Porosimetry

Optimize bioavailability, dissolution profiles, and controlled release through precise porosity characterization of tablets, excipients, and drug delivery systems.

$1.8T
Pharma Market 2026
65%
Oral Drug Products
300%
Bioavailability Improvement
24hr
Extended Release Target

Tablet Porosity & Dissolution

Critical parameters linking physical structure to drug release performance

Immediate Release Tablets

Porosity-Dissolution Relationship

  • Tablet porosity: 15-30%
  • Pore size range: 0.1-10 μm
  • Liquid penetration: <30 seconds
  • Disintegration: <15 minutes (USP)
2026 Insight: Real-time porosity monitoring during compression enables 99.5% batch uniformity.

Key Measurements

  • Mercury intrusion for total porosity and PSD
  • Helium pycnometry for true density
  • BET surface area for active ingredient
  • Tortuosity effects on dissolution rate

Controlled Release Systems

Extended & Delayed Release

  • Matrix porosity: 8-25%
  • Pore connectivity: Controlled
  • Release duration: 8-24 hours
  • Zero-order kinetics: Targeted
Advanced Design: Gradient porosity matrices achieve linear release profiles for 24+ hours.

Critical Parameters

  • Pore network connectivity analysis
  • Swelling-induced porosity changes
  • Erosion vs diffusion mechanisms
  • In-situ dissolution-porosity correlation

Excipient Characterization

Fillers & Diluents

Materials MCC, lactose, starch
Surface area 0.5-2.0 m²/g
Pore volume 0.1-0.5 cm³/g
Compressibility High
Application Direct compression

Critical for tablet hardness and porosity balance

Mesoporous Silica

Type MCM-41, SBA-15
Surface area 500-1200 m²/g
Pore size 2-10 nm
Drug loading 20-40 wt%
Application Solubility enhancement

Transforms poorly soluble drugs to amorphous state

Polymeric Carriers

Materials HPMC, PEG, PVP
Surface area 1-10 m²/g
Swelling index 100-500%
Gel strength Variable
Application Controlled release

Controls drug release through gel layer formation

Advanced Drug Delivery Systems

Nanoparticle Formulations

Enhance bioavailability of poorly soluble APIs through high-surface-area nanocarriers.

  • Liposomes: 50-200 nm diameter
  • PLGA microspheres: controlled degradation
  • Solid lipid nanoparticles (SLN)
  • Surface area: 50-500 m²/g typical
Result: 5-10× bioavailability increase

Injectable Depot Systems

Long-acting formulations utilizing porosity-controlled drug release mechanisms.

  • PLGA microsphere porosity evolution
  • Release duration: 1-6 months
  • Initial burst control via pore blocking
  • Erosion-controlled kinetics
Target: Zero-order release ±10%

Inhalation Products

Porous particle engineering for deep lung deposition and systemic delivery.

  • Particle size: 1-5 μm aerodynamic
  • Porosity: 70-90% for reduced density
  • Surface area controls dissolution
  • FPF >40% with optimized porosity
Achievement: 80% lung deposition

Transdermal Patches

Membrane porosity engineering for controlled permeation and sustained release.

  • Membrane porosity: 40-70%
  • Pore size: 0.1-1.0 μm
  • Flux control: 10-100 μg/cm²/hr
  • Release duration: 1-7 days
Performance: Steady-state in 2-4 hours

Recommended Testing Protocols

Product Type Primary Method Key Parameters Regulatory
API powder N₂ adsorption (BET) Surface area, particle size USP <1058>
Tablets Mercury intrusion Porosity, PSD, tortuosity USP <699>
Excipients BET + MIP combined SA, pore volume, density Compendia specs
Mesoporous silica N₂ at 77 K SA, PSD (BJH/NLDFT) ICH Q6A
Liposomes/NP DLS + BET Size, PDI, surface area USP <1787>
Inhalation BET + aerodynamic sizing SA, MMAD, porosity USP <601>

Industry Case Studies

BCS Class II Solubility Enhancement

Challenge: Improve dissolution of poorly soluble antifungal drug

Solution: Mesoporous silica (SBA-15) carrier with drug loading optimization

  • 800% increase in dissolution rate
  • Drug loading: 35 wt% achieved
  • Surface area: 720 m²/g (loaded)
Impact: FDA approval granted Q1 2026

Extended Release Matrix Optimization

Challenge: Achieve true 24-hour once-daily dosing with narrow therapeutic window drug

Solution: Gradient porosity HPMC matrix with controlled pore network

  • Zero-order release: r² = 0.995
  • Porosity gradient: 22% to 12%
  • Batch variability: <5% RSD
Result: $180M annual revenue product

Inhalable Insulin Formulation

Challenge: Design porous particles for deep lung delivery and rapid absorption

Solution: Spray-dried porous microparticles with controlled internal structure

  • Porosity: 85% (low density)
  • Lung deposition: 76% emitted dose
  • Tmax: 15 minutes (vs 45 min subcutaneous)
Breakthrough: Needle-free diabetes management

Optimize Your Formulations

GMP-compliant testing services for pharmaceutical development and quality control