Supersaturated
Calcium
Phosphate
Rinse
Xerostomia & Mucositis
Xerostomia:
• Dry mouth, or xerostomia, refers to a condition in which the salivary glands in your mouth don't make
enough saliva to keep your mouth wet. Dry mouth is often due to the side effect of certain medications or
aging issues or as a result of radiation therapy for cancer. Less often, dry mouth may be caused by a
condition that directly affects the salivary glands.
Mucositis:
• Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract,
usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer.
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Etiology
• Medications:
• Many prescription and OTC medications cause dry mouth, including antihistamines, decongestants,
hypertensive medications (for high blood pressure), antidiarrheals, muscle relaxants, urinary continence
drugs, some Parkinson's disease medications, as well as a number of antidepressants.
• Cancer treatment:
• Radiotherapy (radiation therapy) to the head and neck can damage the salivary glands, resulting in less
saliva being produced. Chemotherapy can alter the nature of the saliva, as well as how much of it the body
produces.
• Xerostomia has Mucositis as one of the complication
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Oral Mucositis
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Oral Mucositis – Unmet Medical need
• Radiation-induced Oral Mucositis :
• Most common complications during and after radiotherapy for head and neck cancer
• 22-66% of patients undergoing radiation therapy for Head & Neck experience a moderate to severe
degree of xerostomia
• Chemotherapy-induced Oral Mucositis :
• 51% developed Oral Mucositis receiving chemotherapy for solid tumors or lymphoma
• 75–80% of patients who receive high-dose chemotherapy prior to hematopoietic cell transplantation
develop clinically significant oral mucositis
Significantly reduces quality of life (QoL) for many patients who are potentially cured from their cancer but
also poses a major new health problem
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Management of Oral Mucositis
• Mouthwashes with mixed action
—benzydamine hydrochloride, corticosteroids and chamomile
• Topical anaesthetics
—Viscous lignocaine and xylocaine
• Immunomodulatory Agents
—recombinant keratinocyte growth factor
• Mucosal barriers and coating agents
• Antiseptics, antibacterial, antifungal and antiviral agents
—chlorhexidine, povidone iodine and hydrogen peroxide
—Nystatin, clotrimazole and PTA lozenges
• Cytoprotectants
—Beta-carotene (pro-vitamin A), vitamin E and oxpentifylline
• Mucosal Barriers And Coating Agents
—Sucralfate
• Analgesics
—Capsaicin
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Limitations of conventional options
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Supersaturated Calcium Phosphate Rinse
•
Caphosol ( EUSA Pharma)
•
Indication - Oral Mucositis and Dry mouth
•
Presentation - Ampules or in dispersible form
•
Composition
Dibasic Sodium Phosphate 0.032,
Monobasic Sodium Phosphate 0.009,
Calcium Chloride 0.052,
Sodium Chloride 0.569,
Purified Water qs ad (%w/w)
(total sodium content 71 mg/30 mL)
Jazz/EUSA Pharmaceuticals
Dose box (2 x 15mL ampules/dose)-30,120
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Composition
Supersaturated Calcium Phosphate Rinse
* Each pack contains:
* Solution A Sachet
*
*
Dibasic Sodium Phosphate 0.064% w/w,
Monobasic Sodium Phosphate 0.018% w/w
* Solution B Sachet
*
*
Solution A and Solution B upon mixing in
equal volume contains
Calcium chloride 0.104% w/w
Sodium chloride 1.138% w/w
* Dibasic Sodium Phosphate 0.032,
* Monobasic Sodium Phosphate 0.009,
* Calcium Chloride 0.052,
* Sodium Chloride 0.569,
* Purified Water qs ad (%w/w)
(total sodium content 71 mg/30 mL)
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Indications
* Indicated as an adjunct to standard oral care in treating the mucositis that may be
caused by radiation or high dose chemotherapy
* Relief of dryness of the oral mucosa in these conditions is associated with an amelioration
of pain
* Indicated for dryness of the mouth or throat (hyposalivation, xerostomia),
regardless of the cause and regardless of whether the conditions are temporary or
permanent
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How Caphosol work?
Caphosol maintains the functionality of the oral cavity through healing of the oral mucosa.
The ions contained in Caphosol diffuse into the intercellular spaces in the epithelium and
permeate the mucosal lesion(s) in mucositis.
Ions within the mouth such as calcium and phosphate play crucial roles in the healing process:



Calcium ions play a crucial role in the inflammatory process, the blood clotting cascade and
tissue repair.
Phosphate ions may help repair damaged mucosal surfaces. Calcium and phosphate ions aid
in the prevention of dental caries
Bicarbonate reduces the acidity (pH) of the oral fluids, dilutes the accumulation of mucus, and
discourages the colonization of yeast
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Clinical trial establishing efficacy of CAPHOSOL Treatment
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Advantages of Supersaturated Calcium Phosphate Rinse
 Reduces inflammation
 Reduces healing time
 Relieves pain
 Helps patient to eat and speak
 Loosens tough mucous
 Prevents mucous membranes from adhering to each other
 Improves adherence of dentures
 Relieves bad taste
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Direct Competition
• SalivaMAX
• - Supersaturated calcium phosphate powder
that when dissolved in water
• - SalivaMAX is available by prescription
only. SalivaMAX is provided in single use
packets and are mixed with 1 oz. of water to
create a supersaturated calcium phosphate
rinse. Patients swish with SalivaMAX, and it
may be administered several times per day,
depending on the dry mouth severity
Company:
Forward Science
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Composition Comparison
• Magic Mouthwash:





Diphenhydramine
Viscous lidocaine
Antacid
Nystatin
Dexamethasone
• Caphosol:





Dibasic Sodium Phosphate 0.032,
Monobasic Sodium Phosphate 0.009,
Calcium Chloride 0.052,
Sodium Chloride 0.569,
Purified Water qs ad (%w/w)
Other OTC/OTX Mouthwash
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Reasons to select
• - Caphosol is USFDA approved agent used for the prevention and treatment of oral mucositis that may be
caused by radiation or high dose chemotherapy.
• - Caphasol is not available in major EM countries
• - The patient potential is huge
• Head & Neck cancers
• Increasing BMT procedures
• Rising breast cancer and lymphomas cases
• - We have good coverage of medical oncologists and hematologists, having Caphosol in our portfolio will
complement our current offerings
• - We need to add/focus on radiation oncologists for Caphosol
• - Having Caphosol, an innovative brand in our portfolio will help us to build company image in
oncology/hematology fraternity
• - Improves QoL in cancer patients significantly
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Thank you