Suspensions 2

Page 1: Introduction to Suspensions

  • Title: PHAR 202 Towards Unbounded Thinking: Suspensions

  • Instructor: Carol Yousry, Ph.D.

  • Affiliation: School of Pharmacy, NGU

  • Date: Oct-24


Page 2: Learning Outcomes

  • Main Objective: Discuss fundamental colloid science to design, prepare, and assure quality of pharmaceutical products.


Page 3: Learning Objectives

  • By the end of this lecture, you should be able to:

    • Explain the usefulness of suspensions in pharmacy.

    • Describe properties of a good suspension.

    • Discuss formulation, stability, and manufacturing considerations.

    • Explain the utility of viscosity-enhancing, wetting, and flocculating agents with examples.


Page 4: Definition of Suspension

  • Suspension: A dispersion of insoluble solid particles in a liquid.

  • Particle Size: Generally >1 μm up to 10 μm.

  • Comparison: Different from a colloidal system (particle size < 1 μm).


Page 5: Reasons for Using Suspensions

  • Poor Solubility: Some drugs cannot be made into solutions.

  • Taste Masking: Unpleasant tastes may be less noticeable in a suspension (e.g., Paracetamol).

  • Stability: Drugs may be more stable in suspension than in solution or as solids.


Page 6: Properties of a Good Suspension (Part 1)

  1. Particle Size: Small and uniform size (1-10 µm) for a smooth texture.

  2. Comparison: A good suspension is not gritty, while a bad suspension has overly large or varied sized particles.


Page 7: Properties of a Good Suspension (Part 2)

  • Homogenous : Even distribution of particles after shaking; ensures consistent dosing.

  • Visual Example: A good suspension maintains proportional doses, whereas a bad one exhibits significant variations.


Page 8: Properties of a Good Suspension (Part 3)

  1. Viscosity: Must be sufficient to reduce sedimentation rate, yet remain pourable.

  2. Re-dispersibility: Ease of dispersion upon shaking is crucial for maintaining suspension integrity.

    note: the higher the viscosity, the lower the sedimentation rate


Page 9: General Formulation Considerations

  • Key Factors:

    • Physical characteristics of the drug.

    • Solubility and dissolution issues.

    • Dispersibility aspects.

    • Impact of added excipients.

    • Physical and chemical stability—both short-term and long-term.


Page 10: Making a Suspension

  • Initial Steps: Start with the drug having small and uniform particles; maintain small amounts in solution.

  • Temperature Effects: Changes in temperature can alter solubility and lead to Ostwald ripening, where smaller particles dissolve and larger ones grow.


Page 11: Solubility & Dissolution Issues

  • Ostwald Ripening: Alters particle size and distribution; prevention through flat solubility profiles.

  • Flat Solubility Profile: Preferable for lower aqueous solubility drugs, achievable with antisolvents.


Page 12: Dispersibility & Surface Wetting

  • Key Concept: The behavior of a liquid droplet on a single solid particle.

    • High interfacial tension(liquid doesn’t spread around particle) leads to poor suspension.

    • Low interfacial tension(liquid spreads around the particle) indicates good dispersibility.


Page 13: Practical Example

  • Relevance: Remember the importance of proper dispersion techniques—illustrated with a reference to making Turkish coffee.


Page 14: Assessing Dispersibility

  • Contact Angle Assessment: Evaluates dispersibility.

    • Values < 90° indicate good wetting and dispersibility.

    • Values > 90° show poor wetting.


Page 15: Enhancing Dispersion

  • Wetting Agents Role: To facilitate the dispersion of water-insoluble drugs by lowering interfacial tension.


Page 16: Wetting & Dispersion Visualization

  • Effects of Wetting Agents: Enhance dispersion of hydrophobic particles by reducing clumping and facilitating integration into the aqueous medium.


Page 17: Function of Wetting Agents

  • Preventing Containment Adhesion: Coats particles to decrease their tendency to cling to containers, facilitating better dosing.


Page 18: Types of Wetting Agents

  • Surfactants: Used below CMC (Critical Micelle Concentration).

    • Examples: Polysorbates (Tweens), Sorbitan esters (Spans), Sodium lauryl sulfate.


Page 19: More Wetting Agents

  • Hydrophilic Colloids: Provide coating to solid particles.

    • Examples: Acacia, Bentonite, Cellulose derivatives.


Page 20: Additional Wetting Agents

  • Simple Solvents: Aid in displacing air from powder pores.

    • Examples: Alcohols, Glycerol.


Page 21: Sedimentation in Suspensions

  • Measurement of Sedimentation: Ratio of sediment layer volume to total volume (R) quantifies sedimentation.

  • R= HEIGHT OF SEDIMENTED LAYER/ TOTAL HEIGHT OF SUSPENSION


Page 22: Sediment Ratio Calculation

  • Sediment Ratio: Ratio formulated as either:

    • Volume of sedimented layer (Vs) / Total suspension volume (Vt)

    • Height of sedimented layer (h) / Initial height of suspension (h0)


Page 23: Velocity of Sedimentation

  • Observation of Sediment Layers: At different time intervals (e.g., 0, 15, 30 min, 1 h, 6 h), measuring height for sediment analysis.


Page 24: Understanding Sedimentation Velocity

  • Stokes’ Law: Overall sedimentation velocity depends on particle radius, densities, viscosity, and gravity.

  • a = the radius of the solid particles;

  • σ = the density of the solid;

  • ρ = the density of the liquid;

  • η = the viscosity of the liquid;

  • g = the acceleration due to gravity.


Page 25: Desired Sedimentation Pattern

  • Ideal Characteristics:

    • Slow sedimentation by increasing viscosity to retain dispersibility without compromising pourability.


Page 26: Suspending Agents

  • Role of Viscosity Enhancers: Different agents can alter sedimentation patterns and affect dosing precision.


Page 27: Examples of Suspending Agents

    • Common Agents: (viscosity enhancers)

    • Polysaccharides (e.g., Acacia, Xanthan gum),

    • Celluloses (e.g., Methylcellulose),

    • Hydrated silicates (e.g., Bentonite).

    • Carbomers and silicon dioxide (Aerosil).


Page 28: Considerations for Suspending Agents

  • Trade-offs: Over-viscous suspensions may hinder pouring; hence balance needed with potential flocculating agents.


Page 29: Suspension Classification

  • Deflocculated vs Flocculated: Key difference in the presentation and behavior of particles suspended.


Page 30: Characteristics of Deflocculated Systems

  • Settling Characteristics: Slow sedimentation which can lead to caking and complicated redisperse upon settling.


Page 31: Characteristics of Flocculated Systems

  • Behavior Upon Settling: Rapid settlement leading to ease of redisperse, making them preferable in pharmaceuticals.


Page 32: Comparing Flocculated vs Deflocculated Systems

  • Key Differences:

    • Deflocculated: Slow settling, difficult to redisperse, higher risk of caking.

    • Flocculated: Quick sedimentation, easy to redisperse, less caking and presents cloudy appearance.


Page 33: Visual Sediment Comparison

  • Representation of Sediment Dynamics: Comparison in ratio and height of sediment in deflocculated vs flocculated systems.


Page 34: Formulating Flocculated Systems

  • Strategy Choices: Formulators can adjust viscosity and density to manage rates of sedimentation for optimal suspension performance.


Page 35: Importance of Education on Shaking

  • Patient Education: Emphasizing shaking before dosing for maintaining proper suspension characteristics and dosing accuracy.


Page 36: Role of Flocculating Agents

  • Function: Minimize caking while aiming for a partially flocculated system that enhances redisperse potential.


Page 37: Examples of Flocculating Agents

  • Types of Agents:

  • Include electrolytes (e.g. sodium acetate),

  • surfactants, (ionic or non-ionic)

  • polymers, (starch, alginates, cellulose derivatives)

  • carbomers or silicates.


Page 38: DLVO Theory

  • Key Concept: Describes the multiple interactions in suspensions based on the electrical double layer around particles.


Page 39: Exploring the Electrical Double Layer

  • Details on Layer Structure: Composed of various planes that contribute to the overall behavior of particles in suspension.


Page 40: DLVO Potential Interaction Profiles

  • Attraction vs Repulsion: Visual understanding of energy interaction profiles based on particle separation.


Page 41: Effects of Zeta Potential Changes

  • Connections to Dosing: Zeta potential influences suspension reproducibility and sedimentation behavior; management is critical for effective formulations.


Page 42: Moderate Electrolyte Effects

  • Resulting Changes: Higher +ion concentrations decrease zeta potential, affecting stability and promoting flocculation.


Page 43: High Electrolyte Effects

  • Observations: High concentrations lead to aggregation and reduced charge stability among particles, complicating suspension integrity.


Page 44: Zeta Potential Dynamics

  • Isoelectric Effects: Closer zeta potentials lead to more pronounced flocculation effects within the suspension.


Page 45: Example of Bismuth Subnitrate Suspension

  • Initial State: Deflocculated due to positively charged surfaces and controlled by adding KH2PO4 to manage zeta potential.


Page 46: Managing Zeta Potential in Bismuth Suspension

  • Zeta Potential Control: As KH2PO4 increases, zeta potential transitions from positive to negative, crucial for achieving a non-caking flocculated state.


Page 47: More on Zeta Control

  • Key Aspect: Accurate control of the amount of electrolyte added to achieve desired flocculated properties in the suspension.


Page 48: Recap on Flocculating Agents

  • Re-emphasis: The range of agents, including electrolytes and various surfactants and polymers, that affect sedimentation characteristics.


Page 49: Surfactants' Influence

  • Mechanism: Neutralization of surface charge through surfactant addition, affecting particle interactions.


Page 50: Surfacing Effects Explained

  • Concentration Dynamics: Beyond CMC leads to micelle formation; below CMC aids in inter-particle interactions.


Page 51: Bridging Model Elaborated

  • Inter-particle Behavior: Explains the series of reactions leading to floc formation and particle bridging under optimal polymer dosages.


Page 52: Managing Surfactant Concentration

  • Risk Mitigation: Importance of controlling polymer levels to prevent re-stabilization of deflocculated states.


Page 53: Formulation Excipients Summary

  • Function Overview:

    • Wetting Agent: Ensure uniform particle size and homogeneity.

    • Suspending Agent: Assure slow sedimentation rate.

    • Flocculating Agent: Enhance redisperse characteristics.

    • Additional excipients: Buffers, stabilizers, preservatives.


Page 54: Manufacturing Considerations

  • Critical Stage: Initial dispersion of powdered drug with wetting agent is imperative to avoid caking; packaging requires stirred conditions to keep suspension homogeneous.


Page 55: End of Lecture

  • Questions and Engagement: Invitation for learning moments and inquiries regarding suspensions.


Page 56: Recap of Critical Points

  • Suspension Definition: Characterized by small uniform size, homogeneity, slow sedimentation, and redispersibility.

  • Key Considerations: Involves solubility, dispersibility, excipient effects, application of DLVO theory, and surfactants.


Page 57: Further Reading

  • References for More Information:

    • Aulton and Taylor, Aulton's Pharmaceutics, 5th ed, Elsevier, 2017.

    • Florence and Attwood, Physicochemical Principles of Pharmacy, 6th ed, Pharmaceutical Press, 2015.