Manufacturing (SAS 8 and SAS 9)

SAS 8 and SAS 9

Validation

an essential part of good manufacturing practices that establishes confidence that the manufactured products will consistently meet their product specifications

Prospective Validation

to prove or demonstrate that the process will work in accordance with validation protocol prepared for the pilot production trials

Concurrent validation

a process where the current production batches are used to monitor processing parameters

Retrospective validation

conducted for a product already being marked and is based on extensive data accumulated over several lots and over time

Revalidation

usually performed to the confirmation of initial validation for a periodic review

Stage 1- Process Design

the commercial manufacturing process is defined during this stage

Stage 2- Process Qualification

during this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing

Stage 3- Continued Process Verification

an ongoing assurance is gained during routine production that the process remains in a state of control

Calibration

the set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system of measuring the corresponding known values of a reference standard

Validation

the action of proving and documenting that any process, procedure, or method actually and consistently leads to the expected results

Qualification

the action of proving and documenting that any premises, systems, and equipment are properly installed, and/or work correctly and lead to the expected results

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Quality

the suitability of either a drug substance or a drug product for its intended use

Quality by Design

the systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management

Quality by Design

introduced by Joseph M. Juran in 1985

Quality Target Product Profile

a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account

Transdermal Drug Delivery Systems

designed to deliver a therapeutically effective amount of drug across a patient’s skin and in the bloodstream

Single-layer Drug in-adhesive

in this type patches, the adhesive layer serves to adhere the various layer together and is responsible for the releasing of the drug

Multi-Layer Drug in-adhesive

in this type, both the adhesive layer are also responsible for the releasing of the drug and it adds another layer of drug in-adhesive, usually separated by a membrane

Drug reservoir-in-adhesive

the drug layer is a liquid compartment containing a drug solution or suspension separated by a backing layer; rate of release is zero order

Drug matrix-in-adhesive

the matrix system has a drug layer of a semisolid matrix containing a drug solution or suspension

Penetration enhancers

used to attain higher therapeutic levels of the drug and it interacts with structural components of stratum corneum

Adhesives

it must possess sufficient property so as to firmly secure the system to the skin surface and maintain it in position for as long as desired, even in the presence of water

Pressure sensitive adhesives

used to achieve contact between the transdermal patch and the skin

Peel

the resistance against the breakage of the adhesive bond

Track

the ability of a polymer to adhere to a substrate with little contact pressure

Creep

the viscous relaxation of the adhesive bond upon shear

Backing membrane

serves the purpose of holding the entire system together and at the same time protects the drug reservoir from exposure to the atmosphere

Release liner

prevents the loss of the drug that has migrated into the adhesive layer during storage and protects the finished device against contamination

Solvent casting method

the transdermal patches were prepared by this method

Rolling Ball Tack Test

this test measures the softness of a polymer that relates to talk

Folding endurance

it is determined by repeatedly folding one patch at the same place until it broke

Quick stick (peel-tack) Test

in this test, the tape is pulled away from the structure at 90 degrees Celsius at a speed of 12 in/min

Tensile strength

it is determined by the apparatus designed to measure it where the instrument has horizontal wooden platform with fixed scale and attachments for two clips that holds the transdermal patch under test

Shear strength properties

it is also called creep resistance and it is the measurement of the cohesive strength of an adhesive polymer

Rhesus monkey

one of the most reliable models for in-vivo evaluation of transdermal drug delivery in man

Human mode

the final stage of the development of a transdermal device involving collection of pharmacokinetic and pharmacodynamic data following application of the patch to human volunteers

Biophysical model

it is based on steady-state mass balance equation

Nicotine patch

the highest selling transdermal patch in the United States

Estrogen patches

it is prescribed to treat menopausal symptoms, as well as post-menopausal osteoporosis

Nitroglycerin patches

sometimes prescribed for the treatment of angina in lieu of sublingual pills

Clonidine

an antihypertensive drug that is available in transdermal patch form

Selegiline

it became the first transdermal delivery agent for an antidepressant