Handbook Generic Development
Sterile Eye Preparations
A Two Part Development Handbook

Locum International Press

Volume 08 PII (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

This latest authoritative Handbook of Pharmaceutical Generic Development is a practical hand-on workbook covering the total preparation, manufacture and validation of Sterile Eye Preparations (ophthalmic drops, solutions, gels, emulsions and suspensions).

Extensive coverage of sterile validation protocols from washing machines steam sterilizers and lyophilizes. Current advances in pharmaceutical, formulations, legal and regulatory development approaches by industry and agency experts. Explaining in simple terms osmolarity, isotonicity, colligative properties, hydrogels and viscosity agents, co-solvents, optimum pH for actives and preservatives, buffers systems and buffer capacity and preservative choice for each individual active/excipient master formula and tailoring preservative concentration to current product usage, either chronic, acute and multi product dosing procedures and patient/consumer use.

Table of Contents for both US and EU eCTD and CTD modules. Covering the major ophthalmic preservative and excipient systems used today as well as the critical buffer combinations, viscosity-hydrogel systems in aqueous eye solutions and occular suspensions and the advanced formulation use of co-solvents with water-insoluble active materials API's (prostaglandin's antagonists etc) for the preparation of aqueous based ophthalmic solutions (not formulated as a suspension).

Part Two details pharmaceutical legal and regulatory generic development of all modules provide essential development know-how on Sterile Eye Preparations for professional developers to understand the nuts-and-bolts on Sterile Generic ophthalmic development.

TOP 120 PRODUCT FORMULAS
Every form (of solutions, suspensions, drops, gels and emulsion) and all the marketed actives and current ophthalmic eye excipients in use today are thoroughly discussed, tabulated, reviewed and evaluated in both development and regulatory detail including ophthalmic preparations for use in glaucoma, NSAI's, mast cell stabilizers, anti-allergy, ocular anti-infectives, antibiotics, conjunctivitis, corticocsteriods, midriatics, anesthetics, anti-inflamatories, ocular lubricants and artificial tears, among others.

Key documents that goes into an CTD/ANDA are explained in clear English with a FDA prior approved example covering in excess of 120+ of the world's top selling and successful ophthalmic solutions (drops and gels), suspensions and eye emulsions in both multi dose and single dose units.

Every formulation aspect is covered from A to Z in development, scientific and ophthalmic formulation know-how technology. An absolute 'must-have' for today's' ophthalmic manufacturers. No developer should be without this vast technical ophthalmic publication. Updated and expanded annually with the latest ophthalmic products and formulas.

Complete Volume in two parts 1990-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, high-tech schematics, fishbone diagrams, flow charts, formula, graphs, spectra, side-by-side tabulated comparisons, tables in b/w & color. Available in print (soft, hard, spiral soft cover opens flat) or via digital online (drop box), CD (large multinational multi-users require electronic license). Split volume attract a 25% handling and broken volume charge to split the two part volume.

ISSN: 0793 7601 / 0793-761X

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