Title: Corium International Transdermal Patch Technology
1Corium InternationalTransdermal Patch Technology
- Corium International
- 4558 50th Street
- Grand Rapids, MI 49512
- 616.656.4563
2Presentation Outline
- Personal Bios
- Corium Capabilities
- Corium Transdermal/Transmucosal Technology
- Transdermal Functional Requirements
- Anatomy of the Skin
- Transdermal Patch Mfg Process Flow
- Transdermal Patch Unit Operations
- Mix/Coat Processes
- Lamination and Die Cut Processes
- Fill and Seal Processes
- Pouching Process
3Personal Bios
- Steve Klemm Chief Operating Officer
- Bachelor of Science in Chemical Engineering,
Michigan State University - Plant Manager, Director of Global Engineering and
RD for Amway, General Manager for Central States
Precision - Holds 3 patents for specialized delivery systems,
included delayed release - Developed proprietary extraction, dehydration,
emulsion process technologies - Dan Arsulowicz, Director of Project Mgmt
Process Development - Bachelor of Science, Chemical Engineering,
University of Michigan - Masters in Business Administration, Grand Valley
State University - 8 years in Process Development and Manufacturing
of cosmetic, OTC, medical device, and Rx liquid
dose, solid state, and transdermal products.
4Corium International, Inc.
A World-Class Drug Delivery Company that Develops
Pharmaceutical Products for Delivery Through the
Skin Mucosa
5Coriums Capabilities
Concept / Project Planning
Clinical Supply Studies
Commercial Manufacture Launch
Feasibility Development Studies
Mfg Process Development Scale-Up
Continuous Supply Process Improvement
- Depth of RD experience
- Breadth of manufacturing capabilities
- Novelty and flexibility of drug delivery platforms
6Diverse Experience with Commercial Product
Development and Manufacturing
- Transdermal Drug Delivery Systems
- First Nitroglycerin (Nitro-dur)
- First OTC Nicotine (Nicotrol)
- 7-day Estradiol (Fempatch)
- Fentanyl (through Phase III)
- First (and only) Scopolamine and Clonidine
- First Contraceptive (Evra)
- OTC Dermal Delivery Systems
- Wart, Corn and Callus Treatment
- Pain, Poison Ivy and First Aid
- Teeth Whitening
- Medical Device and Diagnostics
- ECK/EKG Monitoring and Diagnostic
- Transcutaneous Electrical Nerve Neuromuscular
Stimulation - Electro-Surgical Grounding Pads
- Fecal Occult Blood Test
- Non-Invasive Glucose Monitoring
- Wound Care Products
- Transparent Film Dressings
- Chronic Wound Treatment
- Wound Closure Strips
7(No Transcript)
8Development Commercial Programs
9Manufacturing RD
Manufacturing Grand Rapids, Michigan
- 160,000 sq ft GMP, DEA, ISO qualified facilities
- Process development and scale-up
- Pilot/Clinical Commercial manufacturing
- In-line labeling, packaging cartoning
- Complete Analytical Testing Capabilities
Research Development Redwood City, CA
- Formulation and product development
- Small-scale prototyping
Basic Applied Research Moscow, Russia
- Research and new technology development at the
Russian Academy of Sciences
10Custom Designed Transdermal / Mucosal Systems
Rapid Onset
25
Intermittent 1
20
Intermittent 2
Continuous Release
15
Blood Level Activity
10
5
0
0
5
12
22
Time
11Corium Transdermal Delivery Systems
Solid State Film System side view
Also applies to Dermal, Mucosal and
Transmucosal Delivery
12Corium Transdermal Delivery Systems
Backing
Drug reservoir
Adhesive
Release liner
Specialized Membrane
Specialized Membrane
Liquid Reservoir System
side view
Also applies to Dermal, Mucosal and
Transmucosal Delivery
13Micro-Delivery Systems
- Minimally invasive micro-delivery array or heat
element for trans-epidermal delivery of
pharmaceutical product - High degree of flexibility in depth of delivery
20 200 µm stratum corneum through to dermis
Stratum Corneum
Viable Epidermis
Dermis
Nerve Endings Blood Vessels
14Basic Functional Requirements
- Adhesion to Skin
- Initial Tack
- Wear Duration
- Overlay Options
- Delivery of Drug Active
- Assay, Impurity
- Controlled Release Drug Delivery Rate
- Removal from Skin
- Minimal irritation and force
15Anatomy of the Skin
16Transdermal System Unit Operations Requirements
17Transdermal Systems Scale-Up and Manufacturing
Options Mix Process
- Mix Technology
- Scrapewall
- Used for low shear, gentle mixing and to
facilitate heat transfer - Disperser
- High Shear mixing technology to facilitate
material dispersion - Homogenizer
- High shear mixing technology to control particle
size (e.g. improve API particle size uniformity)
18Transdermal SystemsCritical Control PointsMix
Process
- Mix Process
- Typical Critical Process Parameters
- Agitation Speeds
- Agitation Times
- Mix Temperatures
- Typical Response Variables
- Blend Appearance
- Blend Drug/Enhancer Assay
- Blend Viscosity
- Particle size
19Transdermal Systems Scale-Up and Manufacturing
Options Coating Process
- Coating Scale
- Lab Scale Batch Coating
- Pilot/Production Scale Continuous Coating
- Application Technology
- Comma Coating
- Knife Over Roll Coating
- Slot Die Coating
- Drying Technology
- Impingement Drying
- Flotation Drying
- Drying Capacity
- Single-Zone
- Multi-Zone Drying
20Transdermal SystemsCritical Control
PointsCoating Process
- Coating Process
- Typical Critical Process Parameters
- Coating Technology
- Dryer Temperature
- Dryer Air Flow
- Coating Line Speed
- Typical Response Variables
- Residual Solvent
- Coat Weight
- Drug/Enhancer Assay
21Transdermal SystemsSample Coating Line Equipment
Layout
22Transdermal SystemsCritical Control
PointsLamination and Die Cut Process
- Lamination and Die Cut Process
- Process Options
- Individual Die Cut Parts
- Die Cut into Reels
- Typical Critical Process Parameters
- Die condition
- Web Tension
- Lamination Pressure
- Typical Response Variables
- Part Size and Shape
- Drug/Enhancer Assay
- Drug Release Rate
23Transdermal SystemsSample Die Cut and Lamination
Equipment Layout
24Transdermal SystemsCritical Control PointsFill
and Seal Processes
- Fill and Seal Processes
- Typical Critical Process Parameters
- Fill Volume, placement
- Seal Time, Temperature, Pressure
- Typical Response Variables
- Fill Weight
- Drug/Enhancer Assay
- Seal Integrity
- Drug Release Rate
25Transdermal SystemsCritical Control
PointsPouching Process
- Pouching Process
- Process Options
- Reel Feed Via Cross Feed Station
- Pick and Place
- Typical Critical Process Parameters
- Sealing Time
- Sealing Temperature
- Sealing Pressure
- Typical Response Variables
- Pouch Seal Integrity
- Pouch Burst Strength
26Transdermal SystemsSample Pouching Equipment
Layout
27QUESTIONS??THANK YOU!!