Prednisolone Acetate Ophthalmic Suspension

Description

Prednisolone Acetate Ophthalmic Suspension (1% w/v)

Healthy Inc is a specialized global supplier and exporter of advanced ophthalmology, immunology, and high-potency corticosteroid therapeutics. We provide ultra-high-purity, kinetically balanced Prednisolone Acetate Ophthalmic Suspension, manufactured in WHO–GMP certified, high-precision sterile ophthalmic facilities. This “Premium Glucocorticoid” is a strategic export to surgical eye hospitals, specialized clinics, and government health ministries, serving as the globally preferred intervention for the management of steroid-responsive ocular inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Product Overview

This formulation operates as a “Nuclear Receptor Modulator.” It physically penetrates the corneal barrier to enter the cells of the internal eye, switching off the genetic “alarms” that lead to sight-threatening swelling and scarring.

• Mechanism 1 (Lipophilic Penetration): Prednisolone in the Acetate form is physically more oil-soluble than the phosphate form. This allows it to physically bypass the corneal epithelium more efficiently, reaching higher concentrations in the aqueous humor.

• Mechanism 2 (Cytokine Suppression): It physically binds to intracellular glucocorticoid receptors, inhibiting the synthesis of phospholipase A2. This stops the production of prostaglandins and leukotrienes at the source.

• Mechanism 3 (Leukocyte Migration Inhibition): It physically prevents white blood cells from gathering at the site of injury, effectively stopping the “vicious cycle” of inflammatory tissue destruction.

Product Composition & Strength

We supply this product as a Sterile, Buffered Ophthalmic Suspension, optimized for high ocular bioavailability and rapid symptom relief.

Technical & Logistics Specifications

• HS Code: 3004.32.00 (Medicaments containing Adrenal Cortical Hormones / Ophthalmic)

• CAS Number: 52-21-1 (Prednisolone Acetate)

• Dosage Form: Sterile Eye Drops (Ophthalmic Suspension)

• Packaging: Sterile LDPE Dropper Bottles (5ml / 10ml). Our specialized ophthalmic packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• Nano-Suspension Engineering: Our manufacturing process utilizes High-Shear Micronization to ensure that Prednisolone particles are ultra-fine. This prevents the “gritty” feeling in the eye and ensures every drop delivered through the tip has the exact 1% concentration.

• Aseptic Filling Excellence: Our manufacturing process utilizes Class 100 (ISO 5) Sterile Filling Lines, ensuring 100% microbial safety for post-surgical eyes.

• Hormonal Segregation: We utilize Dedicated Steroid Blocks to ensure zero cross-contamination, meeting the strictest international B2B safety standards.

Primary Indications

• Ophthalmology: Treatment of Severe Uveitis, Iritis, Cyclitis, and Allergic Conjunctivitis.

• Post-Operative Care: Management of inflammation following Cataract Surgery, corneal transplants, and Vitreo-retinal procedures.

• Trauma: Prevention of scarring and reduction of swelling following chemical burns or foreign body injury.

Dosage & Administration

• Standard Regimen: Typically 1 to 2 drops in the affected eye(s) 2 to 4 times daily. During the initial 24 to 48 hours, the dosage may be increased to 2 drops every hour.

• Administration: Shake well before use. Apply to the conjunctival sac. To minimize systemic absorption, apply pressure to the tear duct for 1 minute after instillation.

• Duration: Use should be tapered as the inflammation subsides.

Safety Warning: For Ophthalmic Use Only. Vision Warning: May cause temporary blurred vision; do not drive until vision is clear. IOP Monitoring: Prolonged use (over 10 days) requires monitoring of Intraocular Pressure (IOP) to prevent steroid-induced glaucoma. Contraindication: Do not use in viral (Herpes), fungal, or tuberculosis eye infections.

Global Export & Contract Manufacturing

Healthy Inc is a premier Ophthalmic and Surgical Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume sterile ophthalmic suspensions. Whether you are a Tertiary Eye Hospital in the Middle East or a B2B Pharma Marketplace partner in Africa, the CIS, or LATAM, we ensure secure, WHO-GMP compliant delivery.