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OPTHALMIC PREPARATIONS

MISS ATIYAMR.ASIM QURESHI

MISS SAIMA BAIGMISS ERUM

MISS FARAH NAZ

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INHALARSAn inhaler or puffer is a medical device used

for delivering medication (aerosols)into the body via the lungs. It is mainly used in the treatment of asthma andChronic Obstructive Pulmonary Disease (COPD). 

Aerosols are products that are packaged under pressure and contain therapeutically active ingredients that are released upon activation of an appropriate valve system.

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TYPES OF INHALARSMetered-dose inhalers (MDI)It is the most common type of inhaler is the

pressurized metered-dose inhaler(MDI). In MDIs, medication is most commonly stored in solution in a pressurized canister that contains a propellant, although it may also be a suspension.

The MDI canister is attached to a plastic, hand-operated actuator. On activation, the metered-dose inhaler releases a fixed dose of medication in aerosol form.

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Dry powder inhalers (DPI)These inhalers release a metered or device-

measured dose of powdered medication that is inhaled through a DPI device.

NebulizersNebulizers supply the medication as an aerosol

created from an aqueous formulation.Analgesic inhalersTo deliver analgesic agent via inhalation usually

volatile anesthetics used for induction of anesthesia

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What is In Process QCIPQC is an on line inspections of products as

available during production to confirm product compliance. Monitoring the production process reduces the risk of substandard quality and works to ensure that all other aspects of contractual obligations are met.

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MANUFACTURING PROCESSManufacturing process controls usually

include: monitoring of proper formulation and

propellant fill weight and pressure testing, leak testing, and valve function testing of the finished aerosol.

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Topical Aerosols Delivery rate and delivered amountOnly perform these tests on containers fitted with

continuous valves.

Procedure: Select not less than 4 aerosol containers, weigh, actuate

each valve for 5 seconds, weigh each container again.Calculate the average delivery rate in g per second, for each

container.Calculate the total weight loss from the container. This is

the delivered amount.

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PRESSURE TESTOnly perform this test on topical aerosols fitted with

continuous valves.Select 4 aerosol containers, determine the pressure in

each container by placing a calibrated pressure gauge on the valve stem.

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LEAKAGE TESTOnly perform on topical aerosols fitted with

continuous valves.Select 12 aerosol containers, weigh each

container, mg W1, allow to stand in upright position at temp. 25C for not less than 3 days,

weigh again each container, record the weight, mg as W2, calculate the leakage rate mg/year.

365x(24/t) (W1-w2)The requirements are met if the average leakage rate per year

for the 12 containers is not more than 3.5% of the net fill weight, and none of the containers leaks more than 5% of the net fill weight per year.

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LEAKAGE TEST CONT.If 1 container leaks more than 5% per year, and if

none of the containers leaks more than 7% per year.Determine the leakage rate of an additional 24

containers as directed. Not more than 2 of the 36 containers leak more than

5% of the net fill weight per year, and none of the 36 containers leaks more than 7% of the net fill weight per year.

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FLAME EXTENTION TESTThe product is sprayed for 4 seconds into a flame, the

extension of the flame is measured by a ruler.

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SPARY PATTERN TESTBy spraying the content of the container on a rotating

paper impregnated with a dye solution, coloured spots are produced Homogeneity of the colour indicates a homogenous spray pattern.

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TOTAL NUMBER OF DISCHARGE PER CONTAINER• Perform this test on topical aerosols fitted with dose-

metering valves. • The requirements are met if all the containers or

inhalers tested contain not less than the number of discharges stated on the label.

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UNIFORMITY OF DOSSAGE FORMThe test is required for aerosols fitted with dose-metered valves,

metered dose inhaler and dry powder inhalers.The drug content of at last 9 of the 10 doses collected from one

inhaler, are between 75% and 125% of label claim, and none is outside the range of 65% to 135% of the label claim.

If the contents of not more than 3 doses are outside the range of 75% to 125%, but within the range of 65% to 135% of label claim, select 2 additional inhalers and follow the procedure for analyzing 10 doses from each.

The requirements are met if not more than 3 results, out of the 30 values, lie outside the range of 75% to 125% of label claim and none is outside the range of 65%to 135% of label claim

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PARTICAL SIZEThe particle or droplet size distribution in the spray

discharged from metered-dose inhalers or from dry powder inhalers are important characteristics used in judging inhaler performance.

Inhaler aerosol

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Thank You