PCCA Mucolox™ – Providing a unique solution for painful oral conditions
Two of the most common areas where compounding pharmacists are asked to find solutions are for painful oral conditions such as dry mouth (xerostomia) and oral mucositis.
Dry mouth may be caused by other prescribed medication, aging, nerve damage, smoking and snoring. It is commonly seen in patients with health conditions such as Sjögren’s syndrome, HIV/AIDS, stroke and cancer.
Oral mucositis refers to the inflammation and ulceration of the oral mucosa which occurs as a complication of radiation or chemotherapy. It typically begins approximately five to ten days after initiation of treatment and lasts for seven to fourteen days. It most frequently affects the oral mucosa, but may also impact the length of the gastrointestinal tract. While low grade oral mucositis presents as soreness and erythema, severe mucositis may affect a patient’s ability to eat, drink and speak, to a point where discontinuation of treatment may be the only option.
Goals of therapy, therefore, are to control pain in the mouth, reduce the duration and severity of the lesions and decrease the incidence of ulcerations.
Although oral mucositis is a common complication of radiation therapy and chemotherapy, there is no ONE effective approach to treatment. Recognised therapies include oral debridement, use of antibacterial and antifungal rinses, and topical and systemic pain management.
It is not uncommon for a “swish and spit” mouth rinse formulation to be prescribed. Common ingredients which are incorporated into these mouth rinses include corticosteroids, antihistamines, antifungals, antibiotics and local anesthetics.
Each of these ingredients present specific formulation challenges, typically because the poor palatability of the drugs concerned may lead to poor compliance.
A significant limiting factor in the preparation of mouthwashes for oral pain is the short contact time between the oral rinse and the painful area of ulceration. Ideally a base with improved muco-adhesion would provide better contact time and not be washed away and therefore provide an improved treatment outcome.
Understanding the needs of compounding pharmacists in the field is critical to the development of new innovative bases. The research and development team at PCCA were able to develop a unique muco-adhesive base using a combination of naturally occurring polymers. They also recognised that it was critical to evaluate this base for its safety and toxicology profile due to the improved contact time between the base and the oral mucosa.
As a result, PCCA compounding pharmacists now have access to PCCA Mucolox™ which can be used alone or with active pharmaceutical ingredients for treatment of painful conditions such as persistent mouth ulcers, oral mucositis and dry mouth.
The advanced adhesive properties in PCCA Mucolox™ help to create a gradual and continued release of the drug(s) leading to improved contact, and can be diluted with water to adjust the viscosity and coating effects.
It is free of gluten, casein, dye, alcohol and parabens which makes it suitable for a wide range of patients with specific dietary or anti-allergy requirements. It is pleasant tasting with a slight sweetness, which helps to cover the bitterness of the active drugs used.
In order to evaluate its safety profile, PCCA conducted studies on human oral, nasal and vaginal mucosa. Results indicate that PCCA Mucolox™ is potentially as safe as water.
Prescribers and compounding pharmacists can have the confidence to safely incorporate the unique muco-adhesive polymer base Mucolox™ as a delivery system without causing further harm or discomfort to their patients.
Increased contact time between the medication and the oral mucosa is likely to reduce the need for frequent dosing and increase the effectiveness of each dose administration, thereby improving the likelihood of a positive treatment outcome.
Successful treatment of conditions such as dry mouth or oral mucositis can have a profound impact on the welfare of patients and is one of the most rewarding areas of compounding pharmacy.
If you have patients who may be helped by using this unique product, contact PCCA by visiting pccarx.com.au or calling 02 9316 1500.