Podcast
Questions and Answers
What factor does NOT influence the rate of mass transfer across a polymer?
What factor does NOT influence the rate of mass transfer across a polymer?
Which mathematical model describes a constant release rate of a drug?
Which mathematical model describes a constant release rate of a drug?
What happens to the release rate in First Order Release as the amount of drug decreases?
What happens to the release rate in First Order Release as the amount of drug decreases?
In Square Root of Time Release, how does the release rate decrease over time?
In Square Root of Time Release, how does the release rate decrease over time?
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Which factor will lead to a decreased flux of drug release from a polymer?
Which factor will lead to a decreased flux of drug release from a polymer?
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What is the effect of a larger area on the drug release from a polymer?
What is the effect of a larger area on the drug release from a polymer?
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Which release model is generally considered not important for controlled release applications?
Which release model is generally considered not important for controlled release applications?
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What characterizes Zero Order Release on a graph of release rate versus time?
What characterizes Zero Order Release on a graph of release rate versus time?
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What is the primary purpose of wax matrix systems in medications like potassium chloride?
What is the primary purpose of wax matrix systems in medications like potassium chloride?
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Which of the following is an example of a product that uses the Geomatrix system?
Which of the following is an example of a product that uses the Geomatrix system?
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What characteristic do swelling erodible matrix systems share?
What characteristic do swelling erodible matrix systems share?
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How long can the AccuForm system typically retain a dosage form in the stomach?
How long can the AccuForm system typically retain a dosage form in the stomach?
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Which type of system is characterized by keeping the dosage form in the stomach for an extended period?
Which type of system is characterized by keeping the dosage form in the stomach for an extended period?
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What type of coating is NOT typically involved in coated particle systems?
What type of coating is NOT typically involved in coated particle systems?
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What is one example of a medication that utilizes a swelling system?
What is one example of a medication that utilizes a swelling system?
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Which of the following describes the primary feature of swelling erodible matrix systems?
Which of the following describes the primary feature of swelling erodible matrix systems?
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What is the first step in the workflow for developing a biologic drug?
What is the first step in the workflow for developing a biologic drug?
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Which factor is NOT contributing to the high production cost of biologics?
Which factor is NOT contributing to the high production cost of biologics?
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Which purification method is crucial for ensuring the purity of recombinant proteins?
Which purification method is crucial for ensuring the purity of recombinant proteins?
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What type of host cells are considered the easiest and cheapest to use in biologic manufacturing?
What type of host cells are considered the easiest and cheapest to use in biologic manufacturing?
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What characteristic of prodrugs allows them to provide prolonged drug release in depot injections?
What characteristic of prodrugs allows them to provide prolonged drug release in depot injections?
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Which type of antibodies tend to have the lowest immunogenicity and toxicity?
Which type of antibodies tend to have the lowest immunogenicity and toxicity?
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What is a primary concern in mRNA-based antibody therapy?
What is a primary concern in mRNA-based antibody therapy?
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Which is an example of a long-acting testosterone prodrug?
Which is an example of a long-acting testosterone prodrug?
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Which phase of clinical trials primarily focuses on safety testing?
Which phase of clinical trials primarily focuses on safety testing?
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What are the two mechanisms through which bioerodible microspheres release drugs?
What are the two mechanisms through which bioerodible microspheres release drugs?
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What type of contaminants must be removed during recombinant protein purification?
What type of contaminants must be removed during recombinant protein purification?
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Which polymer is used in the formulation of Lupron Depot?
Which polymer is used in the formulation of Lupron Depot?
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How does the Atrogel Delivery System facilitate drug release?
How does the Atrogel Delivery System facilitate drug release?
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Which aspect of Invega Sustenna contributes to its slow dissolution?
Which aspect of Invega Sustenna contributes to its slow dissolution?
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What is a unique feature of SUBLOCADE in drug delivery?
What is a unique feature of SUBLOCADE in drug delivery?
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What is the significance of the lipophilic nature of prodrugs in depot injections?
What is the significance of the lipophilic nature of prodrugs in depot injections?
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What is a significant advantage of mRNA-based therapies over traditional recombinant protein therapies?
What is a significant advantage of mRNA-based therapies over traditional recombinant protein therapies?
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Which step is NOT part of the mechanism by which mRNA therapies work?
Which step is NOT part of the mechanism by which mRNA therapies work?
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What is a challenge associated with mRNA-based therapies?
What is a challenge associated with mRNA-based therapies?
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Why is the isoelectric point (pI) important for proteins?
Why is the isoelectric point (pI) important for proteins?
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Which statement about mRNA vaccines is correct?
Which statement about mRNA vaccines is correct?
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Which of the following is a potential benefit of mRNA encoding for personalized therapy?
Which of the following is a potential benefit of mRNA encoding for personalized therapy?
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What is a consequence of the body's cells expressing the spike protein from an mRNA vaccine?
What is a consequence of the body's cells expressing the spike protein from an mRNA vaccine?
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How does the pH affect protein charge relative to its isoelectric point?
How does the pH affect protein charge relative to its isoelectric point?
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What characteristic distinguishes biosimilars from generic drugs?
What characteristic distinguishes biosimilars from generic drugs?
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Which of the following statements about the administration routes of generic drugs and biosimilars is true?
Which of the following statements about the administration routes of generic drugs and biosimilars is true?
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What factor contributes to the higher production costs of biosimilars?
What factor contributes to the higher production costs of biosimilars?
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How does the immunogenicity of biosimilars raise safety concerns?
How does the immunogenicity of biosimilars raise safety concerns?
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In terms of testing requirements for biosimilars, which factor is essential for evaluation?
In terms of testing requirements for biosimilars, which factor is essential for evaluation?
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What is a notable difference in the half-lives between biosimilars and generic drugs?
What is a notable difference in the half-lives between biosimilars and generic drugs?
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Which statement accurately describes the manufacturing process of biosimilars?
Which statement accurately describes the manufacturing process of biosimilars?
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What must biosimilars demonstrate to achieve FDA approval?
What must biosimilars demonstrate to achieve FDA approval?
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Study Notes
Advanced Drug Delivery
- Aims to optimize drug delivery, with two main approaches:
- Temporal control (controlling timing, e.g., extended release)
- Spatial control (targeting to needed site)
Why Advanced Drug Delivery?
- Benefits to patients:
- Improved safety and efficacy (steady blood levels, avoiding spikes)
- Increased convenience and compliance (reduced dosing frequency)
- Repatenting drugs:
- Creating extended-release versions to extend patent protection and generate revenue after patent expiry.
Ideal Drug Delivery System Characteristics
- Delivers drug at the perfect time throughout treatment
- Delivers drug only to the site of action
Advanced Drug Delivery Systems
- Many different types, some mechanical (e.g., pumps)
- Most are based on polymers.
Types of Carrier Particles
- Carrier particles (e.g., liposomes, microspheres) used for:
- Controlling drug release
- Targeting drugs to specific sites
Polymers in Advanced Drug Delivery
- Essential components, large molecules made up of repeating units (natural or synthetic)
- Used to:
- Control drug release rate
- Target drug to specific sites
Mass Transfer Across Polymers
- The movement of molecules across polymers.
- The rate of drug release depends on mass transfer rate across the polymer.
- Factors affecting rate are area of contact, permeability, and concentration gradient.
Patterns of Drug Release
- Three main mathematical models:
- Zero-order: Constant release rate over time.
- First-order: Release rate proportional to remaining drug, decreasing over time.
- Square root of time release: Rate decreases linearly with the square root of time.
Types of Polymer Systems for Controlled Release
- Diffusion Devices: Drug release based on diffusion through the polymer, reservoir and matrix systems.
- Reservoir systems: Drug dissolved in a saturated solution surrounded by a polymer membrane that controls release.
- Matrix systems: Drug evenly dispersed in a polymer matrix, releasing drug as polymer degrades.
- Swelling systems: Drug dispersed in a polymer matrix that swells upon contact with body fluids, expanding pores and increasing release rate.
- Osmotic systems: Utilize osmotic pressure to force drug release. Semi-permeable membrane surrounding a drug compartment, water enters the compartment, creates pressure, forces drug release.
Chemical Controlled Systems (Bioerodible Polymers)
- Drug dispersed in a polymer matrix that degrades over time, releasing the drug, typically by hydrolysis.
- Advantages include no removal required (biocompatible breakdown products).
Depot Injectables
- Long-term drug delivery technology, commonly administered subcutaneously or intramuscularly.
Suspensions
- One of the oldest methods, involving gradually dissolving drug crystals in water or oil.
Prodrugs
- Inactive compounds that are metabolized in the body to release the active drug moiety. Fat-soluble, stay in the depot, release gradually.
Bioerodible Microspheres
- More advanced form of depot injectables, consisting of drug particles uniformly dispersed in a biodegradable polymer matrix.
- Drug release through gradual polymer degradation.
Liquid Crystal Nanotubes
- Newest technology, drug dissolved in a biocompatible solvent, which solidifies upon contact in body fluids.
Implants
- Subcutaneously placed for long-term drug delivery, rich in fat, low blood perfusion and nerve density.
- Polymer implants controlled release via biodegradability or pumps.
- Membrane-controlled reservoir systems: Consist of a drug reservoir in a saturated solution, surrounded by a controlled-rate membrane, resulting in zero-order release. Example is Nexplanon.
Mechanical Implants
- Use pumps for positive pressure delivery to specified sites.
External Pumps
- Worn externally, positive pressure to deliver medication in fluid form, categorized as electronic or stored-energy.
- Examples: Hospital infusion pumps, ambulatory infusion pumps, PCA pumps, Insulin pumps.
Spatial Control & Targeted Drug Delivery Methods
- Specific sites within the body, methods include:
- Liposomes: Phospholipid bilayer, capsule that protects and targets drugs, used to deliver various drugs.
- Albumin Nanoparticles: Paclitaxel bound to albumin, delivering it intravenously, avoiding toxic excipients in conventional formulations.
- Antibody-Drug Conjugates (ADCs): Antibody component targets specific cells while the cytotoxic drug destroys cells.
Biologics Workflow and Manufacturing
- Long and expensive process (12-15 years, millions).
- Steps involved (research and design).
Clinical Trials
- Phase 1 (safety testing), 2 (efficacy/safety), 3 (efficacy/safety in larger population).
Factors Influencing Biologic Drug Cost & Safety
- Manufacturing complexity, host cell type affects cost.
- Immunogenicity and toxicity, choosing human sources reduces immunogenicity.
mRNA-Based Antibody Therapy
- mRNA encoding targeted antibodies is introduced into cells in the body for expression.
Types of Oral Controlled Release Systems
- Matrix Systems (dissolving and non-dissolving).
- Gastro Retentive Systems (maintain drug in stomach for prolonged period).
- Coated particle systems (encapsulating drug)
- Membrane Controlled Systems.
- Osmotically Controlled Systems.
- Ion Exchange Systems
- Delayed Release systems.
Transdermal Drug Delivery Patches
- Patches deliver medication through the epidermis for systemic purposes
Key Concepts:
- Biosimilars (similar versions of existing biologics)
- Manufacturing processes of biologics
- Challenges of delivering proteins and peptides
- Various routes of administration and design choices
- Factors impacting stability, biodegradability and target site effectiveness.
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Description
This quiz explores the principles and benefits of advanced drug delivery systems, focusing on both temporal and spatial control of drug release. It discusses the importance of optimizing drug delivery for improved patient compliance and safety, as well as the use of various carrier particles and polymers. Test your knowledge on these innovative drug delivery strategies.
