Description
Hydrocortisone Oromucosal / Buccal Tablets (2.5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oral medicine, dentistry, and targeted localized-delivery therapeutics. We provide ultra-high-purity, kinetically precise Hydrocortisone Oromucosal Tablets (2.5 mg), manufactured in WHO–GMP certified, high-precision bio-adhesive oral solid dosage facilities. This “Mucoadhesive Localized Corticosteroid” is a high-value, highly specialized export to dental hospitals, ENT clinics, oral pathology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, rapid-relief intervention for severe Recurrent Aphthous Stomatitis (canker sores) and erosive mucosal lesions.
Product Overview
This highly advanced formulation acts as a targeted biological band-aid. Instead of flooding the entire patient’s bloodstream with steroids, it is engineered to stick violently to wet mucosal tissue, sealing the painful ulcer from oral bacteria while slowly trickling a potent anti-inflammatory payload directly into the damaged cells.
The “Bio-Adhesive Shield & Local Immunosuppressor” Specialist:
- Mechanism 1 (The Localized Genomic Blockade): Severe mouth ulcers are caused by a localized hyperactive immune response that destroys the mucosal lining. When the 2.5mg pellet dissolves directly over the ulcer, Hydrocortisone penetrates the surrounding cells, binds to glucocorticoid receptors, and aggressively shuts down the localized production of inflammatory cytokines. This instantly halts the tissue destruction and rapidly accelerates healing.
- Mechanism 2 (The Bio-Adhesive Hydrogel Matrix – CRITICAL): The human mouth is a highly hostile environment for targeted drug delivery due to constant saliva flow and tongue movement. This tablet utilizes advanced mucoadhesive polymers. When it makes contact with saliva, the tablet does not disintegrate; it hydrates into a thick, sticky hydrogel. This gel physically bonds to the mucosal glycoproteins, creating a protective mechanical barrier over the exposed nerve endings of the ulcer, providing instant pain relief while the steroid goes to work.
- The “Zero Systemic Toxicity” Advantage: Because the dose is microscopic (2.5 mg) and is absorbed almost entirely at the local tissue level, the drug bypasses the massive systemic side effects associated with oral swallowed steroids (like weight gain, bone loss, or adrenal suppression). It is a highly localized strike against inflammation.
Product Composition & Strength
We supply this product as a Precision-Blended, Mucoadhesive Pellet/Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the highly hygroscopic polymers do not prematurely swell from atmospheric humidity.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Hydrocortisone (as Sodium Succinate or Acetate) USP/Ph.Eur. | 2.5 mg | Global Oral Pathology Standard: The definitive micro-dose engineered specifically for localized mucosal absorption, maximizing ulcer healing while neutralizing systemic exposure. |
| Excipients | Carbomer / Hypromellose (HPMC) / Lactose Monohydrate / Polycarbophil / Magnesium Stearate | Bio-Adhesive Polymers / Matrix Former / Diluent / Lubricant (Engineered utilizing elite hydrophilic polymers that instantly cross-link upon contact with saliva, converting the hard tablet into an immovable, slow-release mucosal patch) |
*Pack Sizes: 10×10 Alu-Alu Blisters or Tubes of 20 (Optimized specifically for the short-term, acute treatment of cyclical ulcer outbreaks).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Dental Distributors, and Hospital Procurement Boards.
| HS Code | 3004.32.00 (Medicaments containing corticosteroid hormones – Dentistry/Oral Medicine) |
| CAS Number | 50-23-7 (Hydrocortisone) |
| Dosage Form | Oromucosal / Buccal Pellet Tablet (Slow-Dissolving Bio-Adhesive) |
| Packaging | Heavy-Gauge Alu-Alu Blisters (STRICTLY MANDATORY). Mucoadhesive polymers (like Carbomer) act like molecular sponges. If exposed to standard PVC blisters in tropical climates, they will pull moisture from the air and swell into useless gel. Strict barrier packaging guarantees absolute physical integrity across Zone IVb. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Bio-Adhesive Polymer Engineering & Low-Compression Dynamics (CRITICAL COMPLIANCE): Compressing a tablet designed *not* to break apart requires intense thermodynamic precision. If a generic press uses too much force, the tablet becomes a rock that will not hydrate into a gel. If pressed too lightly, it falls apart in the mouth and is swallowed. Our dedicated oral-delivery suites utilize precise, low-compression rotary presses and strict ambient humidity controls (RH < 30%) to create a perfect matrix that guarantees exactly 2 to 4 hours of steady mucosal adhesion and drug release.
Therapeutic Indications (Human Use)
Indicated for the targeted, localized management of severe oral inflammatory conditions:
- Recurrent Aphthous Stomatitis (RAS): Rapid pain relief and accelerated healing of severe, painful mouth ulcers (canker sores).
- Oral Lichen Planus: Localized management of chronic, autoimmune erosive lesions on the buccal mucosa and gums.
- Traumatic Ulcers: Healing of severe abrasions caused by ill-fitting dentures or orthodontic braces.
Dosage & Administration
Recommended Dosage (Strictly as per Dental/ENT Guidelines):
- Standard Dosing: One 2.5 mg tablet should be applied to the ulcer 4 times a day, ideally after meals and at bedtime.
- The “Do Not Swallow” Rule (CRITICAL CLINICAL DIRECTIVE): The patient must NOT suck, chew, or swallow the tablet. The tablet must be placed in close proximity to the ulcer and allowed to slowly dissolve into a gel. If swallowed, the local therapeutic effect is completely lost.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Oral Candidiasis (Thrush) Warning: Because the drug suppresses the local immune system to stop inflammation, it creates a perfect environment for oral fungi to overgrow. Prolonged use heavily increases the risk of severe Oral Thrush (Candida albicans infection).
- Viral/Bacterial Lesion Contraindication (FATAL TO TISSUE): ABSOLUTE CONTRAINDICATION: These tablets must NEVER be used on ulcers caused by the Herpes Simplex Virus (cold sores) or acute bacterial infections (like Syphilis or untreated Gingivitis). Applying a steroid to a viral infection will massively accelerate the virus, leading to severe, spreading tissue necrosis.
- Duration Limit: If the ulcer does not show signs of healing after 7 days of treatment, therapy must be stopped and the patient evaluated for oral squamous cell carcinoma (mouth cancer).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Dental/ENT Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Bio-Adhesive Therapeutics, Oromucosal Formulations, and Segregated Corticosteroids. Whether you are looking for a reliable Government Tender Supplier for dental clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.









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