Medical devices · Private label
Pharyndol ProtectCare for sore throats
and pharyngitis
Relieving sore throat from two hours and supporting recovery through local physical action. Pharyndol Protect is an oral spray for the symptomatic treatment of mild to moderate acute pharyngitis of viral or bacterial origin, in adults and children aged 3 and over. It soothes pain and irritation, reduces redness and swelling, and makes swallowing easier.
Its film-forming glycerol technology combines osmotic cleansing and protection of the throat surface. Supplied in a 30 mlbottle, with carton and instructions for use, this medical device provides targeted spray application. It is available to partners looking to offer a sore throat solution under their own brand, supported by clinical results on early relief and recovery.
Your sore throat product,
under your brand
Clinical study
Randomised, open-label, multicentre pilot study; 103 adults analysed.
Population
Adults and children aged 3 and over.
Indication
Symptomatic treatment of mild to moderate acute pharyngitis of viral or bacterial origin.
Benefits
for patients
- Relieves sore throat from 2 hours.
- Immediate action (osmotic mechanical action).
- Soothes irritation and reduces throat swelling.
- Forms a protective film and helps clean the throat.
- Supports faster recovery from acute pharyngitis.
- Over 98% naturally derived ingredients.
- Glycocyanidin-a complex composed of 100% plant-derived ingredients.
Mode of action
Pharyndol Protect deposits a film on the throat mucosa. Selected polymers in the Glycocyanidin-a complex help stabilise this film and retain targeted agents within it. Three complementary functions act simultaneously:
- Cleaning and reducing swelling: osmotic action draws fluids towards the film, promotes the removal of surface contaminants and helps reduce swelling and discomfort.
- Protecting the irritated throat: the film limits direct contact with irritants and creates an environment favourable to natural mucosal repair.
- Capturing targeted agents: the polymers retain viral surface proteins and proteases within the film on the throat, without entering the tissues.
Osmotic mechanical action starts on application. Clinical relief develops during treatment, with improvement in pain documented from two hours.
Clinical study · Acute pharyngitis
Clinical study
Early relief and more patients achieving complete recovery. A randomised, open-label, multicentre pilot study followed adults with acute sore throat for up to 14 days. Of 109 randomised patients, 103 were analysed: 60 in the PHN group and 43 receiving usual care. Planned enrolment ages were 18 to 65; patients completing PHN treatment were aged 19 to 63.
| Benefit assessed | Result with PHN | Comparison |
|---|---|---|
| Severe pain after 2 hours of treatment | 3.3% of patients, or 2/60 | 50.0%, or 30/60, before treatment in the same group |
| Treatment stopped following complete recovery at 10 days | 95.0 %, or 57/60 | 65.1%, or 28/43, with usual care; p < 0.05 between groups |
| Antibiotic use during the study | 6.7 %, or 4/60 | 32.6%, or 14/43, with usual care |
Severe pain was defined as a score of 7 to 10 on a 0-to-10 scale. The two-hour result was observed during the initial repeated-application phase and describes change within the PHN group. Complete recovery combined the absence of pain, irritation and redness with a return to normal throat bacterial counts. Antibiotics remained available in both groups at the physician's discretion. The p < 0.05 threshold indicates a statistically significant difference for recovery.
Good tolerability observed in this study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Pharyndol Protect is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | PHN |
| Public name | Pharyndol Protect |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Adults and children aged 3 and over |
| Category | Throat — pharyngitis |
| Full official indication | Symptomatic treatment of mild to moderate acute pharyngitis of viral or bacterial origin |
| Composition | Film-forming glycerol, Glycocyanidin-a |
| Format / volume | 30 ml oral spray, with carton and instructions for use |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture; do not refrigerate or freeze |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio SAS |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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