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.