INHALATION PREPARATIONS ( AEROSOLS )
Defination :
Inahalation Preparation are liquid or solid dosage forms intended for administration as vapours or aerosols to the lung in order to obtain a local or systemic effect. They contain solution or dispersion of one or more active ingredients which may be dissolved or dispersed in a suitable vehicleThere are two types of Pressurized Metered Dose Inhalers :
1. Two phase system consisting of gas and liquid
2. Three phase system consisting of gas, liquid and solid or liquids.
STANDARD TESTS OR EVALUATION :
Pressurised Metered – Dose Preparation –
1) Description : It should comply with Specification of Products.
2) Content of active ingredient delivered per actuation : Shall Comply with the specification.
3) Uniformity of delivered dose : The preparation complies with the test if 9 out of 10 results lie between 75 to 125 % of the average value and all lie between 65 to 135 % . If 2 or 3 values lies out side the limits of 75 – 125 %. Repeat the tests for two more inhalers. Not more than 3 of 30 values lie out side the limits of 65 – 135 %.
4) Particle size :
The number of pariticles longer than 20 micron meter dosent exceed 50 and no particles exceeds 100 micron meter in length.
5) Number of deliveries per containers : The number of deliveries so discharged in the test for particles size is not less than the number stated on label.
6) Deposition of emitted dose : as per IP or the specification.
7) Leak Test :
A average leakage rate of the 12 containers should not more than 3.5 % of the net fill weigh per container and none of the containers leaks more than 5 % of the net fill weight per yearPOWDER FOR INHALATION :
Powder for Inhalation are presented as single dose powders or multi dose powders. For pre- metered inhaler, the inhaler is loaded with powders pre- dispensed in capsules or other suitable pharmaceutical dosage form.
1) Description : It should comply with Specification of products.
2) Uniformity of delivered dose : The Preparation complies with the test if 9 out of 10 results lies between 75 – 125 % of the average value and all lie between 65 - 135 % . If 2 or 3 value lies out side the limits of 75 -125 % . repeat the test for two more inhalers. Not more than 3 of the 30 values lies out side the limits of 65 – 135 %,
3) Uniformity of content : As given in capsules.
4) Number of deliveries per container : The number of deliveries so discharged in the test for particles size is not less than the number started on label
1. Presented By :
Mr.Traymbak S. Shinde
M. Pharm ( second year )
INHALATION PREPARATIONS
( AEROSOLS )
&
POWDER FOR INHALATION :
1
2. 2
INHALATION PREPARATIONS ( AEROSOLS )
Defination :
Inahalation Preparation are liquid or solid dosage forms intended for administration as
vapours or aerosols to the lung in order to obtain a local or systemic effect. They contain
solution or dispersion of one or more active ingredients which may be dissolved or
dispersed in a suitable vehicle.
Inhalation preparation intended to be administered as aerosol ( dispersion of solid or
liquid particles of active ingredient in a gas ) are administered by pressurized metered –
dose inhaler or by powder inhalers.
Pressurised Metered Dose inhalers are dosage form containing therapeutically acitive
ingredients that are packed under pressure in a sealed container and are released as a fine
mist of spray up on actuation of a suitable valve system.
3. 3
There are two types of Pressurized Metered Dose Inhalers :
1. Two phase system consisting of gas and liquid
2. Three phase system consisting of gas, liquid and solid or liquids.
STANDARD TESTS OR EVALUATION :
Pressurised Metered – Dose Preparation –
1) Description : It should comply with Specification of Products.
2) Content of active ingredient delivered per actuation : Shall Comply with the
specification.
3) Uniformity of delivered dose : The preparation complies with the test if 9 out of 10
results lie between 75 to 125 % of the average value and all lie between 65 to 135 % . If
2 or 3 values lies out side the limits of 75 – 125 %. Repeat the tests for two more
inhalers. Not more than 3 of 30 values lie out side the limits of 65 – 135 %.
4. 4
4) Particle size :
The number of pariticles longer than 20 micron meter dosent exceed 50 and no particles
exceeds 100 micron meter in length.
5) Number of deliveries per containers :
The number of deliveries so discharged in the test for particles size is
not less than the number stated on label.
6) Deposition of emitted dose : as per IP or the specification.
7) Leak Test :
A average leakage rate of the 12 containers should not more than 3.5 % of the
net fill weigh per container and none of the containers leaks more than 5 % of the net
fill weight per year.
5. 5
POWDER FOR INHALATION :
Powder for Inhalation are presented as single dose powders or multi dose powders. For
pre- metered inhaler, the inhaler is loaded with powders pre- dispensed in capsules or
other suitable pharmaceutical dosage form.
1) Description : It should comply with Specification of products.
2) Uniformity of delivered dose : The Preparation complies with the test if 9 out of 10
results lies between 75 – 125 % of the average value and all lie between 65 - 135 % .
If 2 or 3 value lies out side the limits of 75 -125 % . repeat the test for two more
inhalers. Not more than 3 of the 30 values lies out side the limits of 65 – 135 %,
3) Uniformity of content : As given in capsules.
4) Number of deliveries per container : The number of deliveries so discharged in the
test for particles size is not less than the number started on label.
6. 6
5) Microbial contamination : Total viable aerobic bacterial count shall be not more
than 100 CFU per g of the powder.
E.coli – absent in 10 g of the powder.
Salmonella- absent in a 50 g of the powder.
S.Aereus – absent in 10g of the powder.
P. aeruginossa – absent in 10 g the powder.
