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Dr. Sharma's Lecture on Ophthalmic Compounding in PHR3325C, Cheat Sheet of Chemistry

Pharmaceutical SciencesOphthalmologyCompounding Pharmacy

A lecture presentation on pharmaceutical compounding of ophthalmic products delivered by Dr. Amit Sharma as part of the PHR3325C course at Komar University of Science and Technology. The presentation covers the basics of ophthalmic products and the compounding process.

What you will learn

  • What are the common types of ophthalmic products and their uses?
  • What are the key steps in the compounding process for ophthalmic products?
  • What are the regulatory requirements for compounding and selling ophthalmic products?
  • What are the safety considerations when compounding ophthalmic products?
  • What equipment is required for compounding ophthalmic products?

Typology: Cheat Sheet

2018/2019

Uploaded on 11/22/2022

liil-anna
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Download Dr. Sharma's Lecture on Ophthalmic Compounding in PHR3325C and more Cheat Sheet Chemistry in PDF only on Docsity! Lecture -5 Pharmaceutical CompoundingI PHR3325C Presented By:Dr Amit Sharma Assistant Professor of the Pharmacy Department, Komar University of Science and Technology. Address: Chaq Chaq - Qularaisi, Sulaymaniyah - Kurdistan Region-Iraq 1 K o m a r U n iv e r s it y o f S c ie n c e a n d T e c h n o l o g y Ophthalmic Products 1 Ideal Characteristics . Sterile = Free from foreign particulate matter - Isotonic with lachrymal secretion - PH equal to 7.4 s Optimum viscosity (25-SOcps) s Proper preservati Sterility Autoclaving, bacteria proof filters, bactericide addition Micro-organisms causing eye infections Bacteria Virus = Staphylococcus aureus = Proteus vulgaris = Bacillus subtilis = Pseudomonas aeuroginosa + Adenoviruses Foreign Particles = Aninflamed eye is sensitive to particulate matter les Presence of foreign pa 1) discomfort 2) abrade epithelium 3) pathogenic invasion Clarification of ophthalmic solutions is necessary Filtration medium = microporous plastic membrane = sintered glass = smooth filter paper = Ultrafine state of medicaments in suspensions lsotonicity & pH = Instillation of solution having unfavourable osmotic pressure pH causes of comfort = Sensitivity of eye to variations in osmotic pressure is less than variations in pH = Tears have pH 7.4 and good buffering power Neutralize unbuffered solutions (pH 3.5 — 10.5) pro is small Discomfort is caused due to Concentrated solutions of acidic drugs +Highly buffered solutions “Physical or chemical nature of medicaments and preservatives Ex: Local anaesthetic amethocaine cause discomfort due to = surface activity and = ability to denature proteins Preparation of bactericidal and fungicidal vehicle: > Preservative solution should be freshly made > Storage of stock solution present problems 1. Mercurial compounds incompatible with aluminium 2. strongly absorbed by rubber 3. loss potency in polythene containers 4. Deposition of metallic mercury Benzalkonium chloride = Absorbed by polyvinyl chloride = Develop a deposit when in contact with rubber line Chlorhexidine acetate = Slightly degrades on autoclaving = Inactivated by cork All the above compounds require protection from light Precautions to use Stock solutions in emergency = Caps and rubber closures must be pre-treated = Wads of closures should be of silicon rubber for benzalkonium chloride solution = Chlorhexidine solution should not be over-exposed during autoclaving = Phenyl! mercuric nitrate solutions should be rejected if there is a ine precipitate = Storage solutions to be sterilized before storage and covered with a readily breakable seal 2. solu’ in of drugs and adjuncts = Depending upon the solubility of the medicament ex. Chloramphenicol is more soluble in boric acid-borax buffer of pH 7 = Heating assists solution of preserva ex. Phenylmercuric nitrate or acetate = Some has to be dissolved in cold and in an atmosphere of e nitrogen gas Passing through microporous plastic membrane + Mean pore size of 0.8um/ whatmann filter paper (56 grade) + Particle free solution depends not only on filter but also on particle free equipment and containers Millex filter unit-sealed type Heating in an autoclave = Maintaining at 98-100°C for 30 min. Filtration =Pore size 0.22-+0.02um =Diameter of membranes - 13 & 25 mm e Volume supplied Swinnex holders for small volumes- =Small volume (separable type) "Each container not more than 10ml = Separate containers if more than 10ml =Large volume =Contamination is more = Difficult in storing and usage a Containers gle-Application Packs - Minims unit = Multi-application containers *Amber coloured wt) 1. Traditional eye drop bottle *Neutral glass Teat bottle 2 *Rubber teat 3. Screw capped 4. Plastic bottle Instructions to use Eye drops 1. Wash hands 2. Pull lower eye lid down gently with one hand = 3. If the dropper is separate, squeeze rubber bulb while dropper we is in bottle to bring the liquid into dropper or replace on bottle 4. Holding dropper above eye, drop medicine inside lower lid <s while looking up OS 5. Release lower lid AS 6. Try to keep eye open and not blink for at least 30 seconds < Eye ointment Labelling: =Semisolid preparations based on oleaginous/ >For external use only water washable bases packed in collapsible >Store in cool place tubes for easy transfer in to eye cavity by pressure. =Formulation: 1. Medicament — water/ oil soluble > Discard the preparation one month after its first opening Do not use the preparation if irritation persists Ex: Physostigmine eye drops 2. Ointment base Physostigmine sulphate — 0.5 g = Sterilized by heating method Sodium meta bisulphate — 0.2 g Benzalkonium chloride solution — 0.02 ml & Rreeifromirritation Purified water- qs to 100 ml = Diffuse drug uniformly throughout = Melt at body temperature Usage: > Supplied in conc. forms >» Before use dilute with warm water >Can be store for 2 days. Application: “*Clean eye bath / Sterile fabric dressing If large volume flow through eye. Formulatior 1. Drug — NaCl, NaHCO,, boric acid, borax. 2. Vehicle — water 3. |so-osmotic agent Preparation of eye lotion 1. Dissolution of drug in vehicle 2. Clarification 3. Sterilization Ex: Sodium chloride eye lotion (B.P.C) Sodium chloride —9 g jed water — qs to 1000 mI Solution + 200 ml purified Reicu 1000 mI Transfer Hance) rote Tis eer Secale teeta) by Eryets Mail Sega) eeeniets Containers: = Properly sealed containing screw cap with either rubber, plastic or other impervious cap liner = Must not contain cork = coloured and fluted = Resistant to autoclaving. Labelling: = Not to be taken orally = Avoid contamination during use = Discard any unused part after 24hrs or a week after first opening = FOR EXTERNAL USE ONLY Eye Suspension » Rarely used Conditions: > Drug insoluble in vehicle > Drug unstable in liquid form >For sustained action. Ideal characteristics: 1. Sterile 2. Desired viscosity 3. Isotonic 4. Fine particle size to prevent irritation S. Particle should be uniformly dispersed on shaking 6. Packed in suitable container. Contact lens: = Are small visual devices made with curved pieces of plastic = Shaped in a way to confirm directly to the wearing eye TYPES ry Rigid gas Soft contact lens permeable = Hard hydrophobic “Rigid and flexible(silicone) *Most common lens polymethylmethacrytate *More permeable to oxygen Hydrophilic than soft lens sImmediate comfort i *Better vision,durable *More permeable to oxyge! Easier to clean ficult to get used to ncomfortable to wear Does not allow oxygen to pass Contact lens care Should always be kept clean, disinfected and hydrated using contact lens solutions Contact lens solutions for Rigid gas permeable / Hard lenses: 1. Wetting and Rewetting drop (WRW) 2. Cleaning /Disinfecting/Storage solutions (CDS) 3. Extra strength cleaner (ESC) Contact lens solutions for Soft lenses: 1. Cleaning solution 2. Storage solution (CDS) 1. Wetting and rewetting drop (WRW): > Contains polymeric wetting and cushioning agents > Used for wetting lens before insertion >For longer wear and more comfort Composition of Wetting solution 1. Wetting agent: Polysorbate - 80 (0.5%) 2. Antimicrobial agent : Benzalkonium chloride (0.004%), chlorohexidine actate (0.005%) 3. Isotonicity adjusting substances : NaCL, KCL 4. Buffering agents : Boric acid/borax buffer pH 8.4 — 8.6 5. Thickening agents: Polyvinyl! alcohol or other cellulose derivative 2. Cleaning/| >Sterile soluti infecting/Storage Solution (CDS): n that cleans and disinfects > Provides sterile, hydrating storage g lens wrapage & adherence of contaminants to the lens. n of storage solutions 1. Nonionic surfactant - cleaning 2. Mixture of preservatives — prevent microbial growth Note: change solution frequently as preservative action reduces. 3. ‘Extra Strength’ Cleaner (ESC): = Sterile, non-preserved solution = Cleans surface deposits of oils, lipids, salts and cosmetic residue. Soft Contact lens Hydrophilic, soft & flexible type 1. Cleaning solution - heating in 0.9 % NaCL solution. 2. Storage solution (CDS) Note: Soft lenses absorb drug / preservative from ophthalmic preparations & should be removed before administration. Evaluations of ophthalmic products: 1. Sterility test 2. Clarity test 3. Leakage test Volume of packing: Liquid (10-25 ml) Semi solid (less than 5 g) 4. Pyrogen test Containers: Glass — TYPE-| glass bottles + stoppers for ophthalmic injections & sterile powders Plastic - HDPE, LDPE containers & collapsible tubes. Evaluation of containers: 1. Uniformity of volume 2. Leakage test 3.
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