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    DISSOLUTION

    Uploaded by

    Nagiri Murali
    The document describes a dissolution test apparatus used for in vitro testing of tablets and capsules to provide drug release information and determine compliance with dissolution requirements. It discusses the seven types of apparatus used including basket and paddle types. The principle is that dissolution testing identifies the rate of drug dissolved under set conditions like temperature and stirring speed. It provides the working steps for conducting dissolution tests and notes advantages like determining drug absorption rates but also disadvantages like requiring large amounts of media. Applications include evaluating bioavailability between batches.

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    DISSOLUTION

    Uploaded by

    Nagiri Murali
    52 views3 pages
    The document describes a dissolution test apparatus used for in vitro testing of tablets and capsules to provide drug release information and determine compliance with dissolution requirements. It discusses the seven types of apparatus used including basket and paddle types. The principle is that dissolution testing identifies the rate of drug dissolved under set conditions like temperature and stirring speed. It provides the working steps for conducting dissolution tests and notes advantages like determining drug absorption rates but also disadvantages like requiring large amounts of media. Applications include evaluating bioavailability between batches.

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    DISSOLUTION[1]

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    The document describes a dissolution test apparatus used for in vitro testing of tablets and capsules to provide drug release information and determine compliance with dissolution requirements. It discusses the seven types of apparatus used including basket and paddle types. The principle is that dissolution testing identifies the rate of drug dissolved under set conditions like temperature and stirring speed. It provides the working steps for conducting dissolution tests and notes advantages like determining drug absorption rates but also disadvantages like requiring large amounts of media. Applications include evaluating bioavailability between batches.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    52 views3 pages

    DISSOLUTION

    Uploaded by

    Nagiri Murali
    The document describes a dissolution test apparatus used for in vitro testing of tablets and capsules to provide drug release information and determine compliance with dissolution requirements. It discusses the seven types of apparatus used including basket and paddle types. The principle is that dissolution testing identifies the rate of drug dissolved under set conditions like temperature and stirring speed. It provides the working steps for conducting dissolution tests and notes advantages like determining drug absorption rates but also disadvantages like requiring large amounts of media. Applications include evaluating bioavailability between batches.

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    Practice school SACP

    DISSOLUTION APPARATUS

    Description:
    A dissolution test apparatus is used for in vitro testing of the tablets and capsules. Dissolution
    provides the product release information to know the drug delivery. Dissolution apparatus is
    used through out the product development life cycle, from product release to stability testing
    and study of the product data from product to product. Then after passing or approval from
    the quality control and quality assurance, drugs are sent to markets.
    Types of dissolution apparatus:
    According to united states of pharmacopeia and European pharmacopeia, currently,
    seven types of apparatus are used to identify the characteristics of the solid dosage form.
    1.Basket type: For capsules and is operated at 100 rpm
    2.Paddle type: For tablets and operated at 50 rpm
    3.Reciprocating cylinder: For bed type modified release system
    4.Flow cell: For modified release dosage forms with limited solubility
    5.Paddle over a disc: For transdermal dosage forms
    Principle:
    Dissolution test to identify the rate of drug dissolved into the given set of condition such as
    temperature, pH, and stirring speed. This test is designed to determine compliance with the
    dissolution requirements for solid dosage forms administered orally. This test is intended for
    a capsule or a tablet. Dissolution test apparatus measures the extent and rate of solution
    formation from a dosage form, such as tablet, capsule, ointments.
    Working:
    1.Fix the paddle or basket as per the test required.
    2.Start the stirrer by pressing the RUN switch
    3.Set the RPM by turning the RPM knob clockwise to increase the RPM and anti-clockwise
    to decrease the RPM.
    4.After setting the RPM, lock the knob and stop the stirrer by pressing the reset switch.
    5.Set the time as per requirement by using a thumb wheel switch.

    Department of pharmaceutics
    1.1
    6.Select the mode using the auto manual switch. This switch illuminates in auto mode. In
    auto mode, the instrument will give an alarm after every set interval and the stirrer will keep
    on running.
    7.Add the required volume of the deaerated dissolution medium in the jars as per reqired.
    8.Bring the stirrer unit down by using the up-stop-down switch. Run the apparatus to
    equilibrate the dissolution medium in the jars and check the temperature with a calibrated
    thermometer.
    9.If baskets are used, lift the stirrer unit, down by using up-stop-down switch. If a paddle is
    used, place one tablet/capsule in the jar
    10.The inside distance between the paddle or basket to the jars should be maintained at
    25mm+2mm, during the test.
    11.Cover the jars containing dissolution medium with the lids provided.
    12.Start the stirrer by pressing the start switch. Run the apparatus for the set time.
    13.Collect the sample within+2% f the specified time.

    Advantages:
    -The major advantage of dissolution testing is that the rate of release and extent of absorption
    of a drug is determined by the dissolution of the dosage form.
    -The dissolution test apparatus is robust and simple to use, requiring no specialist to handle.
    -dissolution testing is used to determine the quality of pharmaceutical products.

    Department of pharmaceutics 1.2


    Disadvantages:
    -The major disadvantages of the dissolution process is that the amount of media requires to
    be maintained at each interval time, which feels the analyst uncomfortable.
    -Dissolution requires large amounts of media and takes longer to prepare and adjust the pH of
    buffer.
    -Each drug and product has different properties, so in some cases, there is problem of sticking
    and floating.
    Application:
    -Dissolution testing provides the means to evaluate critical parameters such as adequate
    bioavailability.
    -Dissolution analysis of pharmaceutical dosage forms has emerged as single most important
    test that will ensure quality of product.
    -It can ensure bioavailability of product between batches that met dissolution criteria.
    -Ensure batch to batch quality equivalence both in-vitro and in-vivo.

    Department of pharmaceutics 1.3

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