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463 PHTCompendia requirement for Semisolid
Nahla S Barakat, PhDDept. of Pharmaceutics
College of Pharmacy1430-2009
http://images.google.com.sa/imgres?imgurl=http://www.epscientific.com/product/images/pg5-straightsided.jpg&imgrefurl=http://www.epscientific.com/product/environmental.aspx%3Fid%3D42&usg=__K4pVO-YZXQ1p8oMhT5vp7i9uSpU=&h=231&w=225&sz=14&hl=ar&start=326&um=1&tbnid=sM4E6OCuIdt0UM:&tbnh=108&tbnw=105&prev=/images%3Fq%3Dsemi%2Bsolid%2Bproducts%26ndsp%3D18%26hl%3Dar%26safe%3Dactive%26rlz%3D1R2RNTN_enSA357%26sa%3DN%26start%3D324%26um%3D1http://images.google.com.sa/imgres?imgurl=http://img.directindustry.com/images_di/photo-g/grease-49528.jpg&imgrefurl=http://www.directindustry.com/prod/dow-corning/grease-21122-49528.html&usg=__CQAqK-h_T5s9eFuADBAy-ceaNKM=&h=956&w=900&sz=138&hl=ar&start=10&um=1&tbnid=I8MzWSzezQ3wSM:&tbnh=148&tbnw=139&prev=/images%3Fq%3Dsemi%2Bsolid%2Bproducts%26hl%3Dar%26safe%3Dactive%26rlz%3D1R2RNTN_enSA357%26sa%3DG%26um%3D17/28/2019 463 PHT Semi Solid Products
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IDEALPROPERTIESOFSEMI-SOLIDDOSAGEFORMS
Physical properties
a)Smooth texture
b)Elegant in appearance
c)Non dehydrating d)Non gritty
e)Non greasy and non staining
f)Non hygroscopic
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Storage properties
Stable under various real world storage conditions as per
ICH guidelines. Storage of semisolids should be at temperatures not
exceeding 25 unless otherwise authorized.
They should not be allowed to freeze and must be stored ina well-closed container or, if the preparation contains wateror other volatile ingredients, store in an air-tight container.
The containers are preferably collapsible metal tubes fromwhich the preparation may be readily extruded.
If the preparation is sterile, store in a sterile, airtight,
tamper-proof container.
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Microbial content Minimum fill
Packaging
Storage Labeling
Sterility
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Microbial content
These products should meet the acceptable standards for
microbial content Microbial limits are stated for each preparation in the USP
Ex. Betamethazone valerate oint. USP Must meet the
requirement of test for absence of Staph and Pseudo.
Aeruginisa These organisms have capacity to infect the skin
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To minimize both the type and the number of microorganisms
in unsterilized pharmaceutical product, there should be strict
adherence to environmental control and application of good
manufacturing practice
Dermatological product should be examined for P. aeruginosa
and S. aureus
Rectal, urethral, or vaginal product should be tested for yeast,
moulds because they are common offender at these sites
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Test raw material
Use of acceptable water
In process control
Final product testing
The USP stated that certain products should be routinely tested
for microorganism because the way they are used
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Procedure
10 gm or 10 ml of the products is tested after suitable dilution
and added to a specific media and incubate between 30-35 C
for 24-48 h
For purpose of confirming a doubtful result, a retest on 25 gm
specimen of the product may be conducted.
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The average net content of the 10 containers is not less than
the labeled amount, and the net content of any single container
is not less than 90% of the labeled amount where the labeled
amount is 60 g or 60 ml or less .
Or not less than 95% of the labeled amount where the content
is 60 g/or ml 150 g /or ml.
If this requirement is not met, determine the content of 20
additional containers.
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Leakage test
- Select 10 sealed tubes of the ointment
- Clean and dry the exterior surfaces
- Place the tubes with an absorbent sheet in oven at 60 C 3
for 8 hours
- If leakage is observed from one, but not more than one, of
the tubes, repeat the test with 20 additional tubes - The requirement is met if no leakage is observed from the
first 10 tubes, or if leakage is observed from not more than 1
of 30 tubes tested.
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Ointments and other semisolids are packed in :
Large-mouth jar
Metal or plastic tubes
Well closed containers to protect against contamination
Cool place to protect against product separation by heat
When requires light resistance or opaque container for light
sensitive drugs
In addition to the usual labeling, the USP directs that for
certain ointments and creams include the type of base used
either water soluble or water insoluble
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To ensure within lot-to-lot uniformity;
Viscosity
In vitro release
Texture: feel upon application (grittiness) Particle size distribution
pH, odour, colour
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Design of product quality: product design concepts together
with quality assurance concepts must be developed with
ophthalmic sensitivity as a major consideration
General considerations
Raw materials: The selection of specific raw materials should
include specifications which assure batch-to-batchreproducibility of product quality. Particle size is necessary
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Particulates: The USP definition of an ophthalmic product
include the phrase: free from foreign particles Solution clarity is a requirement (by filtration)
It is equally important to fill into particle-free containers
Glass or plastic containers are normally washed, rinsed with
purified water, finally rinsed with filtered, particulate-freepurified water, then dried and sterilized
The filling operation is carried out in an atmosphere controlled
by laminar flow air control
The standard of Class 100 clean room should apply to themanufacture of ophthalmic products
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Formulation aspects
The formulation of ophthalmic solution requires
consideration of : Drug solubility
Buffer , pH
Tonicity
Clarity Viscosity Antimicrobial preservation
Safety sterility
Stability
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Metal Particle in ophthalmic ointments
Extrude as completely as practicable, the content of 10 tubesindividually into separate clear flat-bottom, 60 mm Petri
dish.
Cover the dishes and heat at 85 C for 2 h, to ensure that a
fully state is obtained.
Allow sample to cool to room temp. and to solidify
Remove the cover and invert the Petri dish on the stage of a
microscope equipped with eye-piece micrometer disk, direct
an illuminator above the ointment at 45 angle.
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Examine the entire bottom of the Petri dish for metal
particles.
Count the number of metal particles that are 50 m or larger.
The requirement are met if the total number of such particles
in all 10 tubes does not exceed 50, and if not more than 1
tube is found to contain more than 8 such particles. Repeat the test on 20 additional tubes,
if the total number of metal particles (50 m or larger) does
not exceed 150 in all 30 tubes tested, and if not more than 3
of the tubes contain more than 8 such particles each.
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Ophthalmic products are contained in low-densitypolyethylene dropper bottles, glass bottles with dropper, or
ointment tubes with an extended tip
Polyethylene is not well suited as a container for easily
oxidized substances
It can not be heat sterilized
Ethylene oxide is used as a sterilant
Adequate control of packaging materials is essential to product
quality
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