OPHTHALMICS PRODUCTS

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Slide 1:

PILOT PLANT SCALE UP TECHNIQUES FOR OPHTHALMIC PRODUCTS PRESENTED BY- NIRANJAN UPADHYAY. M.PHARMA 1 ST YEAR. PHARMACEUTICS. NIMS UNIVERSITY

CONTENTS:

CONTENTS 1. INTRODUCTION. 1 Definition. 2 Types of ophthalmic dosage forms 3. MANUFACTURING OPERATION 1) Area requirement. 2) Equipments as per schedule M. 3) Packaging. 4) Process flow chart. 4. IDEAL PROPERTY OF Ophthalmic preparation. 5.FACTORS AFFECTING OPHTHALMIC stability. .

Slide 3:

6. Quality control tests. 7. Documentation. 8. References

INTRODUCTION:

INTRODUCTION What is Pilot plant : “Defined as a part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by the development of liable practical procedure for manufacture.” R & D Production Pilot Plant Scale-up : “The art of designing of prototype using the data obtained from the pilot plant model.”

Importance of Pilot Plant:

Importance of Pilot Plant Examination of formulae. Review of range of relevant processing equipments. The specification of the raw materials. Production rates. The physical space required. Appropriate records and reports to support GMP.

OPHTHALMICS PRODUCTS :

OPHTHALMICS PRODUCTS Ophthalmic preparation are sterile Product that are intended to be applied to the eyelids or placed in the space between the eyelids and the eyeball.

Ideal property for ophthalmic preparation.:

Ideal property for ophthalmic preparation. Sterility. (Avoidance of pyrogens ) Preservation. Tissue compatibility. Suitable packaging. Must be isotonic with lacrymical fluids. should have P H approx 7.4. viscosity.

Types of ophthalmic dosage forms.:

Types of ophthalmic dosage forms. 1) Solutions- ADVANTAGES -convenience DISADVANTAGES - rapid corneal elimination. - loss of drug by drainage. - No sustained action 2) Suspensions- ADVANTAGES - patient compliance - slow dissolution DISADVANTAGES loss of both solution & suspended solid.

FORMULATION:

FORMULATION (1) Vehicles There are two types of vehicles which are: (1)Aqueous vehicles:- e.g. Water is used as vehicle because water is tolerated well by the body (2)Non-aqueous vehicles:- e.g. Oils and Alcohols, such as, fixed oils, almond oil,, ethyl alcohol, propylele glycol.

(2) Adjuvants:

(2) Adjuvants Thickening agents - methyl cellulose. - carboxy methyl cellulose. - polyvinyl alcohol. - polyethylene glycol. Buffers - Boric acid. - Sodium acid phosphate. - Sodium citrate.

Anti-oxidants.:

Anti-oxidants. They are added to provide protection from Oxidation. e.g Sodium metabisulphite - Sodium thiosulphate - Thiourea . - ascorbic acid. Wetting agents. e.g. Polysorbate 20 Polysorbate 80

Slide 14:

Tonicity Adjusting Agents. Commonly used tonicity adjusting agents are Nacl , Kcl , buffer salts, dextrose,glycerin , propylene glycol and mannitol . Preservatives. - Benzalkonium chloride - Phenylmercuric acetate - Phenylemercuric nitrate

VARIOUS FACTORS AFFECTING STABILITY OF FORMULATIONS :

VARIOUS FACTORS AFFECTING STABILITY OF FORMULATIONS Temperature. pH. Excipients. Oxidation. Light. packaging.

Manufacturing considerations:

Manufacturing considerations Manufacturing Environment: The environment should be sterile and particle-free through: - Laminar-flow should be used throughout the manufacturing area. - Relative humidity controlled to between 40 and 60%. - Walls, ceilings and floors should be constructed of materials that are hard, non flaking, smooth and non-affected by surface cleaners or disinfectants.

Manufacturing Environment: :

Manufacturing Environment:

PROCESS FLOW CHART:

PROCESS FLOW CHART

FLOW DIAGRAM SHOWING ARRANGEMENT OF DIFFERENT AREA:

FLOW DIAGRAM SHOWING ARRANGEMENT OF DIFFERENT AREA

MANUFACTURING OPERATION:

MANUFACTURING OPERATION 1) AREA REQUIREMENT Minimum of 10 m 2 → for ancillary area. Minimum of 25 m 2 → for basic installation. Manufacturing & filling shall be carried out in air –conditioned areas under aseptic condition. The rooms shall be further dehumidified as considered necessary if preparation containing antibiotics are manufactured .

Equipments as per schedule M.:

Equipments as per schedule M. For Ophthalmic solutions & suspensions 1) Jacketed kettle/stainless steel tanks(steam gases electrically heated). 2) Mixing & storage tanks of stainless steel/planetary mixer. 3) Sintered glass funnel. 4) Liquid filling equipments (semi automatic & automatic filling machine).

Slide 22:

For Ophthalmic Ointments 1) Colloid mill/ointment mill. 2) Tube filling & crimping equipment(semi automatic & automatic filling machine). 3) Tube cleaning equipments (air jet type). 4) Tube washing & drying equipments.

EQUIPMETNS:

EQUIPMETNS 1)Thermostatically controlled Hot air oven. (preferably double ended) 2) Autoclave. 3) Air conditioning & dehumidification arrangement. 4) Laminar air flow units. 6) Automatic vial washing machine. 7) Vial drying oven. 8) Distillation unit. 9) Packaging & labeling. 10) Inspection machine.

Multicolumn distillation unit:

Multicolum n distillation unit specially designed columns . (Principles inter stage heat exchange) stainless steal & Teflon. Spiral baffle system.( centrifugal force)

Mixing & Storage Tanks :

Mixing & Storage Tanks

SS Tank with Stirrer Manufacturing vessel :

SS Tank with Stirrer Manufacturing vessel Available from 50 ltrs to 10,000 ltrs . With SS steam jacketed & insulation with SS cladding. Different type of stirrer (paddle/ anchor/propeller) available. Electric heating also possible for small scale.

Jacketed kettle / SS Tank (steam, gas or electrically heated) :

Jacketed kettle / SS Tank (steam, gas or electrically heated)

Triple roller mill:

Triple roller mill - It’s used for grinding ointment, pastes, paints, etc. - Side scrappers moves up and down with compression spring and knob to secure appropriate working pressure

ROTARY TUBE FILLING MACHINE:

ROTARY TUBE FILLING MACHINE Tube holders are of spring loaded type to take care of any tube diameter variation. Fill accuracy : + 98.8 %. Usefull in filling paste, lotion, cream, gums, etc. Accurate tail cutting arrangement. Audio alarm. Output upto 50 - 55 Tubes/minute. Can fill from 3 Grams to 500 Grams. GMP model contact parts SS 304 / SS 316 (As per customer requirement). Power consumption 0.75 HP, 230 Volts / 415 Volts. Overload c protection. memory to indicate the number of filled tubes.

Vial filling machine:

Vial filling machine - Suitable for 2 ml to 30 ml vials - Output Speed up to 120 VPM

Fully Automatic Labeling Machine SBSL-120F:

Fully Automatic Labeling Machine SBSL-120F Fully Automatic, User Friendly, Sticker (Self-Adhesive) Labeling Machine Model SBSL-120F, Suitable to apply accurate Labels on Double Side (Front & Back) of Flat/Oval/Square shaped products

Manual Vial & Bottle Inspection machine :

Manual Vial & Bottle Inspection machine Fully Stainless Steel Finish Compact Design Diving type Filling Nozzles Very High Fill Accuracy.

STEAM STERILIZER or AUTOCLAVE:

STEAM STERILIZER or AUTOCLAVE

PACKAGING:

PACKAGING Plastic containers → ease of use. → little breakage. → less spoilage Large volume intraocular solutions of 250ml &500ml have been packaged in glass. Type 1 glass vials with appropriate stoppers are used for intraocular ophthalmic products administered by injection. Different ophthalmic cap color coding are given by the FDA.

OPHTHALMIC CAP COLOR CODING:

OPHTHALMIC CAP COLOR CODING Color Pharmaceutical class Yellow or blue Beta blockers Gray Non steroidal Pink Steroidal Brown Anti infective Orange Carbonic anhydrase inhibitors Turquoise Prostaglandins Red Mydriatics Green Mitotic

QUALITY CONTROL SPECIFICATION:

QUALITY CONTROL SPECIFICATION 1) Raw material 2) packing material - Description - Compatibility - Moisture content - Stability - Assay of ingredient - Purity 3) In process Product a) Mixing b) Filling - Assay - weight variation - Grittiness - content uniformity - Viscosity - Density - pH

Slide 37:

4) Product Specification a) Microbial specification. - limit for total microbial count. - Absence of specific microorganism as per pharmacopoeia. b) Chemical specification - pH. - Content uniformity. - Chemical potency. c) Physical specification - clarity. - Particle size. - Density. - Viscosity.

Documentation:

Documentation Master formula records. Batch formula records. Equipment & containers records. Filtration & filling records. Batch Packaging & Labeling Records.

Master formula records:

Master formula records Name of the product________________________________________ Name and Weight of API ____________________________________ Name and Weight of Ingredient _______________________________ Description of equipment ____________________________________ Statement of theoretical yield_________________________________ Process and packaging procedure_____________________________ A description of container____________________________________ closure and packaging material _______________________________ In process control during processing ___________________________ In process control during packaging____________________________ Precaution to be taken______________________________________

Batch Manufacturing Records:

Batch Manufacturing Records Name of the company:_________________________ Address:-_____________________ Name of the product___________________ Active pharmaceutical ingredient________________ M F R No. ___________________________________ Batch No._____________________ Batch size ____________________ Mfg. date _____________________ Date of expiry_________________ Requisition slip Sr no Ingredients Item code Standards ATR no Label claim Qty required Qty issued

Equipment & containers records:

Equipment & containers records Description of containers _______________________________________ Q/C report of container ________________________________________ Date ________________________ Equipment used__________________ Cleaning agent used ___________________________________________ Cycle of washing: _____________________________________________ Sign. Of officer______________________ If sterilized by dry heat or autoclave : Articles Date Time when oven started Desired temp. attained Temp. Time when oven switched off

REFERENCES:

REFERENCES Remington-The science and practice of pharmacy 21 st edition volume I Controlled drug delivery by N.K.Jain , Page No.(82,85,86,92,94-96) Indian pharmacopiea , 2007 . vol – 1. Controlled drug delivery by Roop K.Khar & S.P.Vyas , Page No.(384-397,399,403) Modern pharmaceutics edited by Gilbert S. Banker.

Slide 43:

Pharmaceutical dosage forms parenteral medications volume 2 edited by Kenneth E. Avis, Leon Lachman . Pharmaceutical dosage forms Disperse systems volume2 http://www.optisgroup.com/TechnologyEyegate.html.