Medical Converting and Packaging for Transdermal Delivery

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cosmeceuticals
Medical Converting and Packaging for Transdermal Delivery
of Cosmeceuticals, Nutraceuticals, and Aromatherapy
The market for cosmeceuticals, nutraceuticals, and aromatherapy is
rapidly expanding as the ability to deliver these items using transdermal
patches is further refined. From patches for anti-aging products, to
essential oils for homeopathic remedies, to vitamins and nutrients for
soldiers in the battlefield, transdermal patch technology has blossomed
since the introduction of the first nicotine patches decades ago.
Cosmeceuticals, Nutraceuticals, and Aromatherapy
Transdermal delivery became more popular in areas where design and
manufacturing complexity and regulatory monitoring were less intense:
cosmeceuticals, nutraceuticals, and aromatherapy.
Transdermal delivery technology is becoming popular for
cosmeceuticals, nutraceuticals, and aromatherapies.
Cosmeceuticals
What are cosmeceuticals? Most often, a cosmeceutical delivers some
active ingredient through the skin, while cosmetics are more “topical”
in nature. Some industry experts would like to define them as products
that don’t require a prescription, but are only available from
professionals such as doctors, aestheticians, healthcare professionals,
and technicians.
Today’s most popular cosmeceuticals include:
• Teeth whiteners
• Lip protection
• Skincare, especially anti-aging products
• Haircare
• Scarless wound healing, or anti-scarring treatments
www.fabrico.com
Backing
Nutraceuticals
Nutraceuticals can include everything from nutritional
supplements to complete emergency nutritional delivery
systems for those without access to meals for a period of
time, for example soldiers in the field, firefighters, miners,
and astronauts.
Drug/Adhesive
Release Liner
Cleavage Load
Dietary and nutritional supplements benefit from
transdermal delivery:
• Instant and continuous delivery to the blood stream;
• Time-release delivery;
• Delivery of the optimal dosage strength;
• No breakdown in the harsh, acidic digestive system;
• Convenient dosage.
Aromatherapy
Aromatherapy has become increasingly popular for:
• Relaxation and stress relief;
• Increased circulation to warm muscles;
• Mood enhancements.
The use of a transdermal delivery patch can speed delivery
of essential oils, allow for greater effectiveness, as in
applications where magnesium is delivered using a thermal
patch, and deliver therapeutic benefits in conjunction with
other homeopathic treatments.
Elements in Patch Designs
Transdermal patch designs contain a liner, formula/drug,
adhesive, membrane, and backing:
• Liner – protects the patch during storage and is removed
prior to use;
• Formula – supplement, oil, or medication in direct contact
with the liner;
• Adhesive – keeps the components of the patch together,
keeps the patch adhered to the skin and, in new designs,
may include the formula/drug;
• Membrane – in some designs, it controls the release
of the formula/drug from the reservoir;
• Backing – protects the patch from the environment.
Drug-in-adhesive transdermal patch designs contain a liner, adhesive, and backing.
Types of Transdermal Patch Designs
The basic functional requirements for any transdermal delivery
system include adhesion to the skin, both the initial tack and
the duration, delivery of the drug, and eventual removal from
the skin without causing unnecessary irritation. A transdermal
patch design will meet these basic functional requirements
using a custom combination of components.
There are several types of transdermal patch designs: reservoir,
matrix, drug-in-adhesive (DIA), and multi-laminate DIA. Patch
design must consider the properties of the drug, cosmeceutical,
nutraceutical, or aromatherapy, the desired delivery profile, and
the target patient group.
The reservoir type patch contains the drug solution in a liquid
reservoir compartment, separated from a release liner by a
semi-permeable membrane and an adhesive. The membrane
controls the timed release of the liquid drug. Closely related,
the matrix design has a drug that is a semi-solid. In the matrix
design, there is no membrane layer.
Drug-in-adhesive (DIA) systems add the drug directly to the
adhesive that contacts the skin. DIA designs can be single
layer or multi-laminate designs that may add a membrane
between two distinct DIA layers, or multiple DIA layers under
a single backing.
The Role of Adhesives in Transdermal Patches
Selection of the correct adhesive for a transdermal patch is
critical. It affects both drug delivery and the adhesion of the
patch to the skin for the required time period and, ultimately,
its easy and pain-free removal when the therapy is completed.
The right adhesive will work with the formula/drug, the patient’s
skin, and body movements that occur during normal wear.
Custom formulations are often required to meet the specifics
for a transdermal patch.
Acrylic, acrylic-rubber hybrids, polyisobutylene, and styrenic
rubber solutions are used for their good adhesion and ability
to control the rate at which the formula/drug enters the body.
New polymer adhesives are also being modified to improve
solubility and drug diffusion while keeping favorable adhesive
and cohesive properties. These polymers include hydrophilic
pressure-sensitive adhesives (PSAs) that can be applied wet
and still provide good adhesion. Other types of polymer
adhesives include synthetic polymers, such as poly acrylic acid
(PAA) and poly methyl acrylate derivatives, as well as hyaluronic
acid and chitosan. Copolymerization of different polymers is
often used to achieve the correct balance of drug delivery,
adhesion, and release properties.
Putting the Package Together
with the Help of a Medical Converter
Fabrico helps OEMs and contract manufacturers with everything
from initial patch design to selection of the appropriate adhesive
formulation, materials for the backing and release liner,
laminating the materials and adhesives together, selecting
the appropriate cutting technique, and assembling and kitting
the final transdermal patch product.
The choice of backing materials influences the delivery profile,
adhesion, and wearability. The backing might include the
lamination of several layers of materials such as polyethylene
and ethyl vinyl acetate. The backing protects and contains the
drug/formulation, prevents the unwanted absorption of the drug
before application, and controls the evaporation of moisture
through the patch. The release liner must also be carefully
Fabrico offers three Class 10,000 clean rooms, as well as ISO 13485 certification.
selected to protect the adhesive, which may contain the
formulation, until application without interacting with other
components in the design. Fabrico can also suggest the best
packaging for the transdermal patch for shipment and storage
until use.
Fabrico provides slitting, layering, laminating, precision
die-cutting, and packaging of the finished product.
The converting process might entail clean room production;
for example, Fabrico offers three Class 10,000 clean rooms
in its facilities, as well as ISO 13485 certification.
Fabrico can select from servo driven rotary die-cutting,
CNC die-cutting, laser cutting, and water jet cutting to
meet the complex specifications of medical components.
For example, a servo driven rotary die-cutter can maintain tight
tolerances ranging from 0.015” to +/-0.005” at speeds up to
500 fpm, and is ideal for the complex, multi-layer die-cutting,
and lamination that a transdermal patch might require.
For complex foam tape converting, water jet technology
provides clean edges with no distortion. Laser cutting,
kiss-cutting, slitting, and laminating can also be used in
converting for medical and cosmeceutical applications.
About Fabrico
Fabrico’s materials converting capabilities include: custom
design solutions for applications that require slitting, laminating,
and die-cutting. Laser cutting, kiss-cutting, and water jet cutting
are available depending on the application and materials
being used.
Fabrico has a fully-equipped in-house test lab to ensure that materials and
adhesives meet design specifications.
Fabrico has a fully equipped test laboratory to ensure that
customer materials meet designed-in specifications before they
move to the factory floor, often eliminating the need to test
materials at the customer’s facility. The test lab offers:
• Accurate and precise part dimension measurement
and verification;
• Adhesive/release liner testing to determine converting
properties and high speed application characteristics;
• Material strength measurement to ensure that material
meets application requirements;
• Static shear testing to measure the cohesive strength
of the adhesive to withstand a fixed load over time;
• Material weight measurement to determine adhesive
coating weight;
• Microscopic imaging to determine differences between
adhesive and material over time.
Fabrico Headquarters
4175 Royal Drive, Suite 800, Kennesaw, GA 30144
Phone: 678-202-2700 | Fax: 678-202-2702
Toll Free: 800-351-8273 | E-mail: info@fabrico.com
With more than 30 years of materials experience, Fabrico
engineers also understand the impact of material selection
on the overall manufacturing process, and design material
systems that optimize production efficiency and improve
overall cost-effectiveness.
Material Partners
Fabrico has strategic relationships with world-class materials
and adhesives suppliers, such as 3M, Adhesives Research,
Dow Chemical, NuSil Technology, Polymer Technology Corporation,
and Saint-Gobain. Fabrico helps its customers in selecting
the best materials and adhesives for the application. Fabrico’s
extensive network of suppliers helps expedite materials and
adhesives sourcing. All critical material and adhesive properties
are considered in any Fabrico project.
www.fabrico.com
Fabrico is a trademark of EIS, Inc.; 3M is a trademark of the 3M Company.
Loctite is a Registered Trademark of Henkel AG & Co. KGaA.
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