Manufacturing (SAS 7)

SAS 7

Aerosols

refers to various systems ranging from those colloidal to systems consisting of pressurized packages

Pharmaceutical aerosol

an aerosol product coming therapeutically active ingredients dissolved, suspended, or emulsified in a propellant or nature of solvent and propellant

Oral aerosols

are intended for administration as fine, solid particles or as liquid mists and are used for their local action in the nasal area, throat, or lungs

Propellants

responsible for developing the proper pressure within the container and expels the product while the valve is opened

Containers

a component of aerosol package that must withstand pressures as high as 140 to 180 psig at 130 degrees Fahrenheit

Tinplate container

consists of a sheet of steel plate that has been electroplated on both sides with tin

Soudronic system

it is based on electronically controlled resistance welding method that uses a copper wire as an electrode

Conoweld system

it passes the folded body through two rotating electrode rings

Aluminum containers

used to manufacture extruded (seamless) aerosol containers

Stainless Steel containers

are limited to smaller sizes but extremely strong and resistant to most materials and have been used for inhalation aerosols

Glass containers

are available with or without coating with corrosion problems being eliminated and has a greater degree of freedom in the design of the container

Continuous spray valve

it is assembled using high-speed production techniques

Ferrule or Mounting Cup

it is used to attach the valve proper to the container

Valve body or Housing

it contains an opening at the point of attachment of the dip tube

Gasket

it is made from Buna-N and Neoprene rubber

Spring

it serves to hold the gasket in place

Dip tube

it is made from polyethylene or polypropylene

Metering valves

applicable to the dispensing of potent medication

Actuators

ensures that the aerosol product is delivered in the proper and desired form

Spray actuators

an actuator which can be used with pharmaceuticals intended for topical use such as spray-on bandage, antiseptics, local anesthetics, and foot preparations

Foam actuators

an actuator which consist of relatively large orifices ranging from approximately 0.070 inch to 0.125 inch or greater

Solid-stream actuators

an actuator utilized in the dispensing of semisolid products such as ointment

Solution system

a two-phase system that consists of a vapor and liquid phase

Water-based system

a system that can be used to replace all parts of the non-aqueous solvents and can produce spray or foam

Ethanol

it can be used as a co-solvent to solubilize propellant in water

Suspension or Dispersion system

it involves dispersion of active ingredient in the propellant or mixture of propellants

Foam systems

it consists of active ingredients that are dispensed as a stable or quick-breaking foam

Aqueous Stable Foams

a type of foam that is used with hydrocarbon and compressed gas propellants

Nonaqueous Stable Foams

a type of foam that is used with glycols such as polyethylene

Quick-breaking Foams

a type of foam where the propellant is in the external phase

Thermal foams

a type of foam that is used to produce warm foam for shaving

Intranasal aerosols

it is intended to deposit medications into nasal packages for local or systemic effect

Pressure Filling Apparatus

it consists of a pressure burette capable of metering small volumes of liquified gas into the aerosol container under pressure

Cold Filling Apparatus

it consists of an insulated box fitted with copper tubing and the tubings are ccoiled to increase the area exposed to cooling

Gas chromatography

it is used to determine the identity of the propellant

Leak testing

a means of checking the crimping of the valve and must be available to prevent defective containers due to leakage

Spray testing

it serves to clear the dip tube of pure propellant, of pure concentrate, and to check for defects in the valve and the spray pattern

Spray testing

for metered valves, it serves to prime the valve so that it is ready for use by the consumer

Delayed release

it is also called enteric-coated tablets

Delayed release

it refers to systems that use repetitive, intermittent dosing of a drug

Sustained Release

it refers to systems that are designed to achieve a prolonged therapeutic effect by continuously releasing medication over an extended period of time

Controlled Release

it refers to systems that achieves slow release of drug over an extended period of time

Extended Release

it refers to systems that release the drug slower than the normal manner at predetermined rate

Site Specific Targeting

in this case, the target is adjacent to or in the diseased organ or tissue

Receptor Targeting

in this case, the target is the particular receptor for a drug within an organ or tissue

Prolonged Release System

it prevents very rapid absorption of the drug, which could result in an extremely high peak plasma drug concentration

Dose dumping

a phenomenon where by relatively large quantities of drug in a sustained release formulation is rapidly released, introducing potential toxic quantities of the drug into the systemic circulation

Half-life

an index of its residence time in the body

Diffusion Sustained System

characterized by the release rate of a drug being dependent on its diffusion through an inert membrane barrier

Reservoir type

in this system, water insoluble polymeric material encases a core of drug

Matrix type

in this system, the drug is dispersed as solid particles within a porous matrix formed of a water-insoluble polymer

Ion exchange

it uses resins composed of water-insoluble cross-linked polymers

Microencapsulation

a means of applying relatively thin coating to small particles of solids or droplets of liquids and dispersions

Core material

defined as the specific material to be coated and can be solid or liquid in nature

Coating material

it should be capable of forming a film that is cohesive with the core material

Wurster process

it consists of the dispersion of solid, particulate core materials in a supporting air stream and the spray-coating of the air-suspended particles

Multiorifice-Centrifugal Process

a mechanical process for producing microcapsules that utilizes centrifugal forces to hurl a core material particle

Spray Drying

the coating solidification is effected by rapid evaporation of a solvent in which the coating material is dissolved

Spray Congealing

the coating solidification is accomplished by thermally congealing a molten coating material or by solidifying a dissolved coating

Polymerization

it utilizes polymerization techniques to form protective microcapsule coatings in situ