Compounding For Diabetic PatientsPresented to you by Torrey Hills Technologies, LLC

Do You Know?

29.1 million people or 9.3% of the U.S. population have diabetes. All ages, 2012. (National Diabetes Statistics Report,2014)

10 to 15 percent of those with diabetes will have at least one foot ulcer during their lifetime. Overall, diabetics are 15 times more likely to undergo amputation than nondiabetic patients. (Drug Topics , Vol. 146, No. 16)

72%

28%

Diagnosed Undiagnosed

85%

15%

No Foot Ulcer Foot Ulcer

Do You Know?1.7 million more people aged 20 years or older have diabetes problems in the U.S. in 2012. (National Health Interview Survey, 2010~2012)

Over half of all amputations per year are due to diabetes and diabetes-related complications. Most are lower-extremity amputations, such as diabetic foot amputation. This operation numbers about 86,000 per year. (National Institute of Health.)

Diabetes-Related Disorders And Complications

• Skin Disorders

• Diabetic Neuropathy

Diabetes-Related Skin Disorders

• 1 in 3 diabetics will be afflicted with a skin disorder at least once in their lives, according to the American Diabetes Association.

• Diabetic patients frequently experience foot problems, such as heel fissures and diabetic ulcers.

• A diabetic patient’s circulation eventually become compromised as blood vessels in the feet and legs narrow and harden.

• Ulcers typically worsen when poor circulation impairs the healing process, which causes skin infections.

Diabetic Neuropathy & Complications

• Excess blood glucose levels can cause peripheral neuropathy, a common form of nerve damage from diabetes.

• Initially, patients suffering from peripheral neuropathy will experience pain, numbness, burning, and tingling in their legs and feet. These unpleasant sensations may spread to the arms and hands, and cause decreased response to pain and temperature changes, burning feelings, and sharp needle-like pain. As a result, patients may experience difficulties walking.

• Many diabetic patients are prone to foot accidents, injuries, and foot blisters due to poor blood circulation and nerve damage, hindering physical sensations. Without medical attention, patients may experience serious complications, such as skin infections.

Daily Self-Care

• Exercise

• Quit Smoking

• Diabetes Control

• Moisture Frequently

• Eliminate Obstacles

• Toenail Trimming

• Wear Sturdy, Comfortable ShoesDiabetic Foot Care Overview, Robert Ferry Jr., MD

How Compounding Can HelpWound Healing

Diabetic patients can be prescribed compounded medication to treat a range of their symptoms. Phenytoin is an ingredient that may be used topically to promote wound healing. When added to a compounded medication, phenytoin stimulates fibroblast proliferation, facilitates collagen deposition, and promotes both glucocorticoid antagonism and antibacterial activity.

Improved Blood Circulation

Because blood circulation is often impaired in diabetic patients, medications that enhance capillary blood flow can be compounded into a medication and topically applied. For instance, studies have shown that a compounded cream preparation of L-arginine HCL 12.5% has helped to improve both blood flow and body temperature.

Pain Relief

Diabetic neuropathy is usually treated with oral medications, although doctors may recommend other types of treatments to help some patients. Additional active ingredients can be compounded for relieving pain. Capsaicin is an ingredient that has proven beneficial in treating foot pain in diabetic patients.

Sample Formulation – Diabetic Ulcer Treatment

An increase in the incidence of diabetes has resulted in an increase in difficult-to-treat occlusive diabetic ulcers. A topical composition comprising about 6% to about 15% nifedipine and about 6% to about 15% pentoxifylline has proved to be effective in treating severe vascular occlusive wounds.

Ingredients:

• Actives :Nifedipine 6%~15%, Pentoxifylline 6%~15%

• Optional Agents: Antibiotics, potentiating agents, pain treatment agents and mixtures thereof.

• Cream Bases: VanPen (PCCA), Lipoderm (PCCA)

• Direction: Apply the composition to the open Wound, and clean and dress the Wound at least once daily.

(TOPICAL COMPOSITION AND METHOD FOR TREATING OCCLUSIVE WOUNDS, US 20050181028A1, 2005)

Sample Formulation –Improving Blood Circulation

A cream or gel that contains substances such as L-arginine is believed to produce beneficial effects such as warming cold tissues and relieving numbing sensation based on improvement of local blood supply for diabetic patients.

Ingredients:

• L-arginine Hydrochloride (12.5%)

• Choline Chloride (10%)

• Magnesium Chloride (5%)

• Sodium Chloride (5%)

• Base Cream

(SUSTAINED RELEASE OF NITRIC OXIDE TO TREAT EFFECTS OF DIABETES, STIMULATE HAIR GROWTH AND HEAL WOUNDS, US 5895658 A, 1999)

Ointment Preparation

• Weighing of Ingredients

• Incorporation of Ingredients

• The components are mixed until a uniform preparation is attained.

• Packaging

Incorporation Methods

• Ointment Slab and Spatula

• Traditional Mortar and Pestle

• Electronic Mortar and Pestle (Unguator)

• Ointment Mill

When to Use An Unguator

• An unguator can be used to process a wide variety of materials, such as liquids, gels, creams, ointments, and powders.

• Capability ranges from 15gr to 1000gr

• The instrument generates consistent results

When to Use An Ointment Mill

• Ointment mills provide both top quality and high efficiency in the preparation of topical compounds.

• These mills eliminate powder nests and reduce the size of particles, allowing for supreme consistency.

• An ointment mill will produce homogenous compounds with an increased active chemical surface, which increases product effectiveness.

• As a general rule, decreasing particle size will result in a much faster rate of percutaneous absorption.

Torrey Hills T50 Ointment Mill

In Reality …

For Small Pharmacies

• Many of our customers use unguator to accomplish preliminary incorporation

• The mixture then goes through an ointment mill to improve the physical appearance of ointments, further reducing the grittiness of the cream and increasing the rate of percutaneous absorption

Unguator

• Preliminary Incorporation

Ointment mill

• Further reduce particle size

For Larger Pharmacies

• Some of our larger customers use unguator to blend powder and solvent at 2000 RPM first

• A blender is then used to mix it with the base cream

• Afterwards, the mixture goes through our production model ointment mill in big batches

• An electric spinning mill is used as a last step to homogenize the medication to give it a beautiful look

Unguator

Blender

Ointment Mill

Spinning Mill

Filling & Packaging• This is the last step in

prescription fulfillment. Most of the jars range from 8oz to 16oz in capacity.

Airless Pumps Cream Jars

Piston Filler

Press Filler

THANK YOU!

Brought to you by Torrey Hills Technologies, LLC.Award Winning Ointment Mill / Three Roll Mill Manufacturer

http://www.threerollmill.com

6370 Lusk Blvd, Suite F-111

San Diego, CA 92121

Tel: (858) 558-6666

Fax: (858) 630-3383