Transdermal and Topical Drug Development Training Course

Transdermal and Topical Drug Development Training Course

Introduction

The field of Topical and Transdermal Drug Delivery is undergoing a profound transformation, driven by the demand for non-invasive, controlled-release therapeutic systems. These advanced dosage forms, including transdermal patches, semi-solid formulations, and novel microneedle arrays, offer distinct advantages such as improved patient compliance, avoidance of the hepatic first-pass effect, and the ability to maintain stable plasma drug levels over extended periods. This comprehensive training is essential for professionals navigating the complex scientific, technical, and regulatory landscape of these innovative products. Transdermal and Topical Drug Development Training Course is meticulously designed to provide an in-depth understanding of the skin's barrier function, the physicochemical principles governing drug permeation, and the cutting-edge strategies for penetration enhancement, including nanotechnology and physical delivery methods like iontophoresis and sonophoresis.

This course focuses on mastering the entire product lifecycle, from preclinical development and Quality-by-Design (QbD) principles to successful ANDA/NDA submissions for both generic and novel systems. Participants will gain practical expertise in crucial areas like in-vitro permeation testing (IVPT), in-vitro release testing (IVRT), and bioequivalence demonstration for complex topical products, which are critically scrutinized by regulatory bodies like the FDA and EMA. By integrating real-world case studies and focusing on the latest advancements in dermatological formulation and manufacturing scale-up, this program equips drug development scientists and pharmaceutical engineers with the strategic skills to overcome formidable technical challenges. Ultimately, this training will empower teams to strategically innovate, reduce time-to-market, and deliver safer, more effective skin-mediated therapies to patients.

Course Duration

10 days

Course Objectives

1. Master the principles of Skin Barrier Function and Cutaneous Pharmacokinetics to optimize API selection.
2. Design and Formulate Advanced Semi-Solid Dosage Forms and multi-layer Transdermal Patches utilizing QbD principles.
3. Apply cutting-edge Penetration Enhancement techniques, including Microneedles, Nanocarriers, and Iontophoresis.
4. Interpret and generate high-quality In-Vitro Permeation Testing (IVPT) and In-Vitro Release Testing (IVRT) data.
5. Develop robust Analytical Methods and Critical Quality Attributes (CQAs) for complex topical and transdermal products.
6. Strategize for Generic Drug Development by demonstrating Bioequivalence for ANDA submissions.
7. Navigate the specific Regulatory Pathways (FDA/EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
8. Implement a Target Product Profile (TPP) and comprehensive Risk Assessment for formulation challenges.
9. Scale-Up and validate robust Commercial Manufacturing processes for semi-solids and patches using Process Analytical Technology (PAT).
10. Assess product Adhesion, wear properties, and the impact of environmental factors like Applied Heat on drug release.
11. Formulate for Enhanced Stability by addressing challenges like polymorphic changes, excipient compatibility, and packaging selection.
12. Design an effective Clinical Development Strategy and Phase I/II protocol for a novel transdermal system.
13. Utilize principles of Pharmacovigilance and Real-World Evidence (RWE) in post-market surveillance and REMS for high-potency patches.

Target Audience

1. Formulation Scientists/Chemists.
2. R&D Directors/Managers.
3. Analytical Scientists.
4. Regulatory Affairs Professionals.
5. Pharmaceutical Engineers.
6. Quality Assurance/Control Specialists.
7. Preclinical/Clinical Development Researchers.
8. Dermatology and Cosmeceutical Researchers.

Course Modules

Module 1: Skin Anatomy and Drug Transport Fundamentals

• Detailed review of the Stratum Corneum and its formidable barrier function.
• Mechanisms of drug transport.
• Physicochemical properties of drugs suitable for Transdermal Delivery.
• Introduction to Cutaneous Pharmacokinetics and key transport parameters
• Case Study: Analyzing the physicochemical profile of an opioid to determine its suitability for patch delivery.

Module 2: Conventional Topical Dosage Forms

• Formulation and classification of Semi-Solid Dosage Forms: creams, ointments, gels, and lotions.
• Role and selection of Excipients
• Understanding Rheology and its critical impact on spreadability and patient feel.
• Stability and shelf-life challenges unique to oil-in-water and water-in-oil emulsions.
• Case Study: Optimizing the Rheological profile of a generic Diclofenac gel to match the reference product's patient experience.

Module 3: Transdermal Patch Design and Technologies

• Components of a Transdermal Drug Delivery System.
• Design principles of Matrix and Reservoir Patches and rate-controlling membranes.
• Selection of Pressure-Sensitive Adhesives for skin adhesion and drug compatibility.
• Manufacturing techniques for patches.
• Case Study: Designing a Scopolamine patch for controlled-release kinetics to treat motion sickness.

Module 4: Advanced Chemical Penetration Enhancement

• Classification and mechanism of action for primary Chemical Penetration Enhancers
• Strategies for reversible disruption of the Stratum Corneum lipid barrier.
• Toxicity and irritation assessment of chemical enhancers on the skin.
• Synergistic enhancer combinations and optimization studies.
• Case Study: Evaluating the use of a natural terpene to boost the dermal penetration of a corticosteroid.

Module 5: Physical and Novel Enhancement Technologies

• Principles and applications of Iontophoresis and Sonophoresis for active drug transport.
• Development and characterization of Microneedle Arrays for bypassing the Stratum Corneum.
• Utilizing Liposomes, Niosomes, and Nanoemulsions as drug Nanocarriers for targeted delivery.
• Needle-free injection systems and thermal ablation as physical enhancement methods.
• Case Study: Developing a dissolving Hyaluronic Acid Microneedle patch for transdermal delivery of a peptide vaccine.

Module 6: Quality-by-Design (QbD) in Topical Drug Development

• Defining the Target Product Profile (TPP) and identifying Critical Quality Attributes (CQAs).
• Performing Risk Assessment to link CQA's to Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
• Establishment of a Design Space and control strategy for semi-solid manufacturing.
• The role of Process Analytical Technology (PAT) in real-time manufacturing control.
• Case Study: Implementing QbD to control the particle size distribution of an API in a suspension-based ointment.

Module 7: In-Vitro Release Testing (IVRT) and In-Vitro Permeation Testing (IVPT)

• Methodology and use of the Franz Diffusion Cell for IVRT and IVPT studies.
• Selecting appropriate membranes for IVPT.
• Data interpretation: calculating Flux, Permeability Coefficient, and determining drug reservoir exhaustion.
• Establishing a scientifically sound acceptance criterion for comparative IVPT/IVRT studies.
• Case Study: Designing an IVPT protocol to evaluate the bio-comparability of a generic Lidocaine patch.

Module 8: Comparative Bioavailability and Bioequivalence

• Regulatory requirements for demonstrating Bioequivalence (BE) of topical products.
• The use of Pharmacodynamic (PD) and Clinical Endpoint studies in lieu of traditional PK.
• Waivers and special considerations for solutions and products with local action.
• Establishing In-Vitro/In-Vivo Correlation (IVIVC) for certain transdermal systems.
• Case Study: Detailed look at the FDA's requirements for demonstrating BE for a generic Acyclovir topical cream.

Module 9: Analytical and Characterization Techniques

• Measurement of Adhesion and mechanical properties of transdermal patches.
• Techniques for determining API distribution and penetration depth in the skin
• Rheology, particle size analysis, and droplet size for semi-solid characterization.
• Chemical stability testing and forced degradation studies.
• Case Study: Using Tape Stripping and HPLC analysis to quantify drug concentration in the Stratum Corneum to prove dermal targeting.

Module 10: Manufacturing Scale-Up and Technology Transfer

• Challenges in scaling up semi-solid and patch manufacturing processes.
• Validation of cleaning procedures to prevent cross-contamination.
• Equipment selection and qualification for large-scale production.
• Documentation requirements for technology transfer between R&D and manufacturing.
• Case Study: Managing the transfer of a complex microemulsion formulation from pilot plant to commercial Scale-Up, focusing on mixing and homogenization parameters.

Module 11: Stability Testing and Packaging

• Designing an appropriate stability protocol based on ICH guidelines 
• Addressing formulation challenges related to Excipient Compatibility and API degradation.
• Selection of primary packaging materials and their impact on product stability.
• Evaluating potential extractables and leachables from the packaging components.
• Case Study: Investigating a stability failure in a topical cream due to a reaction between the API and a common preservative.

Module 12: Clinical Development Strategies

• Phase I safety and maximum tolerated dose (MTD) studies for transdermal systems.
• Designing Phase II and Phase III efficacy trials for locally and systemically acting products.
• Cutaneous Pharmacokinetic (PK) studies to establish dose proportionality and constant delivery.
• Special considerations for pediatric and geriatric populations (e.g., skin integrity).
• Case Study: Developing a Clinical Strategy for a new hormonal Transdermal Patch, including PK and safety endpoints.

Module 13: US and EU Regulatory Submission Strategy

• Overview of NDA and ANDA requirements for Topical and Transdermal Delivery Systems.
• Preparing the Chemistry, Manufacturing, and Controls (CMC) section for complex dermatological products.
• Addressing specific FDA guidance on adhesion, applied heat, and product quality.
• Regulatory challenges and strategies for novel delivery systems.
• Case Study: Analyzing the common deficiencies in an ANDA Submission for a generic anti-inflammatory gel and devising a strategy to address them.

Module 14: Safety, Adhesion, and Patient Factors

• Evaluation of skin irritation, sensitization, and Contact Dermatitis from patch components/excipients.
• Protocols for testing and quantifying Patch Adhesion and wearability under various conditions.
• Risk assessment for Dose Dumping and manufacturing defects.
• Strategies for maximizing Patient Compliance through improved aesthetics and ease of use.
• Case Study: The Recall of a transdermal patch due to a defect causing uncontrolled drug release upon application of external heat.

Module 15: Post-Market Surveillance and Future Trends

• Implementing Pharmacovigilance and Risk Evaluation and Mitigation Strategies
• Collecting and utilizing Real-World Evidence (RWE) for label expansion and safety monitoring.
• 3D Printing of drug products and Personalized Dosing transdermal systems.
• The role of Digital Health in next-generation Transdermal Drug Delivery.
• Case Study: Analyzing post-market surveillance data for a high-potency opioid patch to refine REMS and educational materials for prescribers.

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.