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PHARMACEUTICAL AER ‘O’SOL:

PHARMACEUTICAL AER ‘O’SOL 1 air of sol

Definition:

Definition Packaging of therapeutic active ingredients in a pressurized system. Aerosols are depends on the power of compressed or liquefied gas to expel the contents from containers. 2

Advantages:

Advantages A dose can be removed with out contamination of materials. Stability is enhanced for these substances adversely affected by oxygen and or moisture. When sterility is an important factor, it can be maintained while a dose is being dispensed. The medication can be delivered directly to the affected area in a desired form, such as spray, steam, quick breaking foam or stable foam. Irritation produced by the mechanical application of topical medication is reduced or eliminated. Ease of convenience of application. Application of medication in thin layer 3

Slide 4:

4 Components of aerosols Propellant Container Valve and actuator Product concentrate =life

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5 Propellant It is responsible for developing the power pressure with in the container and also expel the product when the valve is opened and in the atomization or foam production of the product. # For oral and inhalation eg. Fluorinated hydrocarbons Dichlorodifluromethane (propellent 12) Dichlorotetrafluromethane (propellent 114) # Topical preparation Propane Butane Isobutane # Compound gases Nitrogen Carbon di oxide Nitrous oxide

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Amit M Gupta 6 Containers They must be stand at pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 130 0 F. A. Metals 1. Tinplated steel (a) Side-seam (three pieces) (b) Two-piece or drawn (c) Tin free steel 2. Aluminium (a) Two-piece (b) One-piece (extruded or drawn) 3. Stainless steel B. Glass 1. Uncoated glass 2. Plastic coated glass

Slide 7:

7 Physiochemical properties of propellants Vapor pressure Boiling points Liquid density

Slide 8:

8 Vapor pressure of mixture of propellants is calculated by Dalton’s low which states that total Pressure in any system is equal to the sum of individual or partial pressure of various compounds Raoult’s low regards lowering of the vapor pressure of a liquid by the addition of another substance, States that the dispersion of the vapor pressure of solvent upon the addition of solute is proportional to the mole fraction of solute molecules in solution. The relationship can be shown mathematically : na pa = ------------ p A o =N A p A o ----------(1) na + nb Where, pa = partial vaopr pressure of propellant A, pAo = vaopr pressure of pure propellant A na = mole of propellant A, nb = mole of propellant B NA = mole fraction of component A

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9 To calculate the partial pressure of propellant B : nb pb = ------------ pBo = NBpBo ----------(2) nb + na The total vapor pressure of system is then obtained as : P = pa + pb ----------------------------------(3) Where, P = total vapor pressure of system

Slide 10:

Amit M Gupta 10 Valves To delivered the drug in desired form. To give proper amount of medication. Not differ from valve to valve of medication in pharmaceutical preparation. Types - Continuous spray valve - High speed production technique. - Metering valves Dispersing of potent medication at proper dispersion/ spray approximately 50 to 150 mg ±10 % of liquid materials at one time use of same valve.

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Amit M Gupta 11 Valve components Ferrul or mount cap Valve body or housing Stem Gasket Spring Dip tube

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Amit M Gupta 12 Actuator To ensure that aerosol product is delivered in the proper and desired form. Different types of actuators Spray actuators Foam actuators Solid steam actuators Special actuators

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13 Metered dose inhaler To increased interest in modifying metered dose inhalers (MDIs) to minimize the number of administration error and to improve the drug delivery of aerosols particles into the drug delivery system of the nasal passageways and respiratory tract.

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Amit M Gupta 14 Formulation of pharmaceutical aerosols Contains two essential components Product concentrate Propellant Product concentrate Product concentrate contains ingredients or mixture of active ingredients and other such as solvents, antioxidants and surfactants. Propellant May be single or blend of various propellants Blends of propellant used in a p’ceutical formulation to achieve desired solubility characteristics or various surfactants are mixed to give the proper HLB value for emulsion system. To give the desired vapor pressure, solubility & particle size.

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15 Parameters consideration Physical, chemical and p’ceutical properties of active ingredients. Site of application

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16 Types of system Solution system Water based system Suspension or Dispersion systems Foam systems 1. Aqueous stable foams 2. Nonaqueous stable foams 3. Quick-breaking foams 4. Thermal foams Intranasal aerosols Different mentalities

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17 Manufacturing of Pharmaceutical Aerosols Apparatus Pressure filling apparatus Cold filling apparatus Compressed gas filling apparatus

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18 Large scale equipment Concentrate filler Valve placer Purger and crimper Pressure filler Leak test tank

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19 Quality control for pharmaceutical aerosols Propellants Valves, actuator and dip tubes Testing procedure Valve acceptance Containers Weight checking Leak testing Spray testing

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20 Evaluation parameters of pharmaceutical aerosols A . Flammability and combustibility Flash point Flame extension, including flashback B. Physiochemical characteristics Vapor pressure Density Moisture content Identification of propellant(s) Concentrate-propellant ratio C. Performance Aerosol valve discharge rate Spray pattern Dosage with metered valves Net contents Foam stability Particle size determination Leakage D. Biologic characteristics E. Therapeutic activity

Slide 21:

Amit M Gupta 21 Flame Projection ** This test indicates the effect of an aerosol formulation on the extension of an open flame. ** Product is sprayed for 4 sec. into flame. ** Depending on the nature of formulation, the fame is extended, and exact length was measured with ruler.

Slide 22:

Amit M Gupta 22 Flash point Determined by using standard Tag Open Cap Apparatus. Step involves are  Aerosol product is chilled to temperature of - 25 0 F and transferred to the test apparatus. Temperature of test liquid increased slowly, and the temperature at which the vapors ignite is taken a flash point. Calculated for flammable component, which in case of topical hydrocarbons.

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Amit M Gupta 23 Vapor pressure Determined by pressure gauge Variation in pressure indicates the presence of air in headspace. A can punctuating device is available for accurately measuring vapor pressure.

Slide 24:

24 Density Determined by hydrometer or a pycnometer. This method is use for non aerosol, modification to accommodate liquefied gas preparation. Step involves are  A pressure tube is fitted with metal fingers and hoke valve, which allow for the introduction of liquids under pressure. The hydrometer is placed in to the glass pressure tube. Sufficient sample is introduced through the valve to cause the hydrometer to rise half way up the length of the tube. The density can be read directly.

Slide 25:

Amit M Gupta 25 Moisture content Method used — Karl Fischer method G. C has also been used Identification of propellants G.C, I.R spectrophotometry Aerosol valve discharge rate Determined by taking an aerosol known weight and discharging the contents for given time using standard apparatus. By reweighing the container after time limit has expired, the change in weight per time dispensed is discharge rate, Expressed as gram per seconds.

Slide 26:

Amit M Gupta 26 Dosage with metered valves Reproducibility of dosage each time the valve is dispersed Amt. of medication actually received by the patient. Reproducibility has been determined by assay technique, Another method is that, involves accurate weighing of filled container fallowed by dispersing of several doses, container can reweighed, and difference in weight divided by No. of dose, gives the average dosage.

Slide 27:

Amit M Gupta 27 Net contents Weight method Filled full container, and dispensing the contents Foam stability Visual evaluation Time for a given mass to penetrate the foam Times for given rod that is inserted into the foam to fall The use of rotational viscometers

Slide 28:

Amit M Gupta 28 Particle size determination Cascade impactor Light scatter decay method Cascade impactor Operates on the projected through a series of nozzle and glass slides at high viscosity, the large particles become impacted first on the lower velocity stages, and the smaller particals pass on and are collected at high velocity stages. These practical ranging from 0.1 to 30 micron and retaining on RTI. Modification made to improve efficacy

Slide 29:

Amit M Gupta 29 Porush, Thiel and Young used light scattering method to determine particle size. As aerosols settle in turbulent condition , the change in light intensity of Tyndall beam is measured Sciarra and Cutie developed method based on practical size distribution.

Propellants:

Propellants Types CFC-11 Trichloromonofluoromethane CFC-12 Dichlorodifluoromethane CFC-114 Dichlorotetrafluoroethane HFA-134a Tetrafluoroethane HFA-227 Heptafluoropropane Density, Boiling Point, Vapor Pressure 30

Slide 31:

31 3M's CFC-Free Technology Improves Lung Deposition

Metering Valve:

Metering Valve Generally designed to work in inverted position Critical component Primary function – reproducibly delivery an aliquot of liquid phase in which drug is dissolved or suspended Composed of multiple parts that must be assembled Composition – Dispensing volumes – Valve dispenses volumetrically 32