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Q.C & Ophthalmic

The document outlines quality control tests for parenteral preparations, including sterility, pyrogen, clarity, and leaker tests. It also details ophthalmic preparations, their characteristics, advantages, types, and formulation methods for eye drops, ointments, and lotions. Each preparation type has specific evaluation tests and container requirements to ensure safety and efficacy.

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Prajakta Khule
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17 views25 pages

Q.C & Ophthalmic

The document outlines quality control tests for parenteral preparations, including sterility, pyrogen, clarity, and leaker tests. It also details ophthalmic preparations, their characteristics, advantages, types, and formulation methods for eye drops, ointments, and lotions. Each preparation type has specific evaluation tests and container requirements to ensure safety and efficacy.

Uploaded by

Prajakta Khule
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Quality control tests for parenteral

A) Sterility test
1. Direct transfer method
2. Membrane filtration method
B) Pyrogen test
1. Rabbit test
2. LAL test
C) Clarity test
D) Leaker test
A) Sterility test
1. Direct transfer method-
Direct inoculation of req. volume of sample in 2 test tubes containing a culture
medium- Fluid Thioglycolate Medium ( FTM) & Soyabean Casein Digest Medium
( SCDM)
2. Membrane filtration method-
Membrane filter of 0.45 micron porosity- filter solution- remove filter- cut filter
into two halves.
First half- for bacteria- transfer in 100ml culture media ( FTM) – incubate for 30-
35 NLT 7 days- observe growth in media.
Second half- for fungi- transfer in 100ml culture media ( SCDM) – incubate for
20-25 NLT 714days- observe growth in media.
B) Pyrogen test
1. Rabbit test-
• Injection of sample solution into rabbit through ear vein.
• Temp. sensing probe into rectum cavity of rabbit at depth of 7.5 cm.
• Test solution warmed before injection.
• Temp. recorded at 1,2,3 hours to injection.
• Initially performed on 3 rabbits- not- additional 5 rabbits.
• Prior to 1 hr of injecting sample solution, control temp. of rabbit determined.
• Use only those rabbits whose control temp. do not vary by MT 1.
Interpretation-
• Non-pyrogenic- no single rabbit show rise in temperature of 0.5.
• Condition not met, repeated for additional 5 rabbits.
• Non-pyrogenic- if 3 out of 8 show individual rise in temp. 0.5
2. LAL test
• In-vitro test
• Utilizing gelling property of Limulus Amoebocyte lysate
• Derived from horse shoe crab.
• 0.01ml test sample + LAL reagent– incubation for 1 hr. at 37- mixture analysed for
gel clot.

C) Clarity test
• Freedom from any foreign matter.
• Visually inspected under strong light.
• For liquid forms
• Holding ampoule at its neck against highly illuminating screen.
• White screen for detection black particles.
Black screen for detection white particles.
D) Leaker test-
Ampoule immersed in tank – dye solution ( 0.5 - 1% methylene blue)
No leakage- no colour change in content of vial & ampoule- intact sealing
Leakage- colour change- defective sealing
OPHTHALMIC
PREPARATIONS
• Ophthalmic preparations are sterile, liquid, semi-solid or solid preparations
that may contain one or more active pharmaceutical ingredients intended for
application to the conjunctiva, conjunctival sac or the eyelids

Characteristics of ideal ophthalmic preparations-


• Good corneal preparation.
• Prolong contact time with corneal tissue.
• Simplicity for installation
• Non-irritative and comfortable form
Advantages-
• Accurate dosing to overcome side effects of pulsed dosing.
• Provide sustained & controlled drug delivery.
• Increase ocular bioavailability of drug increasing corneal contact time.
• Provide targeting within ocular globe so as to prevent loss to other ocular
tissues.
• Provide comfort, better compliance to patient & improve therapeutic
performance of drug.

Types of ophthalmic preparations


• Eye drops
• Semi-solid eye preparations( eye ointments )
• Ophthalmic inserts
EYE DROPS
• Eye drops are saline solution having a drug or combination of drugs with or
without excipients administered by ocular route.
• No medication, lubricating & tear replacing- rinse eye drop.
• Installed onto external surface of eye, administered inside ( intraocular) or
adjacent (periocular) to eye.
• Less risk of side effects than oral medicines.
• Also used- itching & redness.
Advantages-
• Moisturize eye, relieves dryness & irritation, promoting comfort.
• Compact & easy to administer than injectables or pills.
• Best delivery for eye- local application.
• Flush eye & prevent irritant from making injury worse or causing an infection.
• Cheap than other
Disadvantages-
• Multidose container- avoid contamination.
• Residence time in ocular cavity is less resulting in loss of bioavailability.
• May trigger allergic reactions.
Types of Eye Drops
• Solutions
• Suspensions
•
Formulation of Eye drops-
1. Active Pharmaceutical Ingredients-
• Ex. Atropine, Anti-inflammatories, anti-infectives etc.
2. Vehicles-
• Aqueous but sometimes oils- drugs that are extremely sensitive to moisture.
• Oils used- highest purity.
3. Surfactants-
• To make solution clear by improving wetting of drug substance in respective
vehicles.
• Non-ionic preferred- lesser toxicity & irritation.
• Ex. Benzalkonium chloride, Tween , span etc.
4. Buffers & pH adjusting substances-
• Normal pH -7.4 will be neutralize by normal buffer of tears.
• Ex. Borate buffer, phosphate buffer, citrate buffer etc.
5. Antioxidants-
• Protect active ingredients from oxidation.
6. Viscosity enhancers-
Inc. viscosity- inc. residence time- inc. penetration & therapeutic effect.
Ex. Polyvinyl alcohol, methyl cellulose, HPMC.
7. Chelating agents-
Heavy metal
8. Tonicity adjusting substances-
Isotonic with lachrymal fluid- damage to ocular tissues.
Ex. Potassium chloride, sodium chloride.
9. Preservatives-
To avoid contamination.
Ex. Benzalkonium chloride, phenyl mercuric nitrate.
Method of preparation of Eye drop-
• Preparation of solution
• Clarification of solution- sintered glass filter, membrane filters 0.45-1.21
micrometer.
• Filling
• Sterilization
Containers-
• Neutral glass containers or plastic container.
• 4ml-8ml
Types-
1) single application packs- disposable tube application made up of
polypropylene.
2) Multiple dose container- flexible plastic material & contain dropping tip
usually covered by cap of the bottle.
Label-
“NOT FOR INJECTION” & “FOR EXTERNAL USE ONLY”

Evaluation of Eye drops-


• same as parenteral
EYE OINTMENT
• These are semi-solid sterile preparations meant for application to ocular
cavity.
• Commonly used for treatment of ocular infection & inflammation.
Advantages-
• Longer contact time & greater storage stability.
• Flexibility in drug choice.
• Improved drug stability
Disadvantages-
• Sticking to eyelids
• Blurred vision.
• Poor patient compliance
• Matting of eyelids
Formulation of ointment-
1. Hydrocarbon bases-
• Theses are mixture of paraffins.
• Soft paraffin used- meting range of soft paraffin between 38-60.
2. Non-emulsified absorption bases-
• Contain one or more paraffins & sterols contain emulsifying agent.
• Ex. Lanoline derivatives, bees wax etc.
3. Water soluble bases/ Aqueous gels-
• Prepared using mixture of different molecular weights of polyethylene glycol to
produce required ointment consistency.
4. Excipients in eye ointments-
• Hydrocarbon-bases- contain lower conc. Of water.
5. Preservatives-
• Anti-oxidants- sodium sulphate.
Preparation-
• Base preparation- melt wool fat, yellow soft paraffin on water bath – add
liquid paraffin- filter though coarse filter paper placed on funnel.
• It is sterilize at 1600C for 2 hr. add medicaments with eye ointment base &
pack in sterile container.
• Procedure should be in aseptic condition.

Evaluation test-
1. Sterility test
2. Leakage test
3. Test for metal particles
4. Test for viscosity
6. Clarity test.
Test for viscosity-
• Using Brookfield viscometer.
Test for metal particles-
• Performed using 10 ointment tubes. Each tube completely removed onto
clean diameter Petri dish which possess a flat bottom. The lid closed the
product heated at 85 for 2 hrs.
• Once product melted & distributed uniformly, it is cooled to room
temperature & lid is removed after solidification.
• Surface is view through optical microscope at 30 X magnification.
Containers-
• Sterilized, collapsible tubes fitted with tamper evident applicator.
• Limit- NMT 5g

EYE LOTION
Eye lotions are sterile aqueous solution intended for use in rinsing or bathing
the eye
Multidose container.
Not contain MT 200ml eye lotion.
Formulation-
Isotonic & iso-osmotic to tears.
Not stored MT 2 days.
Method of preparation-
• Sample + purified water- volume with purified water-filter-sintered glass filter
grade 4-transfer to bottle & sealed- sterilization by autoclaving.
Evaluation test-
1. Sterility test
2. Leakage test
3. Test for metal particles
4. Test for viscosity
5. Clarity test.
6. Assay
Containers-
• Amber colored screw capped fluted bottles are used.
• FOR EXTERNAL USE ONLY
THANK YOU

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