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    USB Disolusi

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    lidha
    The document discusses dissolution testing of pharmaceutical products. It defines dissolution as the molecular solubilization of a drug through the breakdown of its crystal structure. Dissolution testing is used to assess drug release, meet regulatory requirements, develop formulations, ensure manufacturing consistency, and correlate in vivo and in vitro performance. Challenges include maintaining sink conditions for poorly soluble drugs. The main apparatuses described are baskets, paddles, rotating cylinders, and flow-through cells. Proper controls of temperature, medium, apparatus, and sampling are also discussed.

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    USB Disolusi

    Uploaded by

    lidha
    48 views17 pages
    The document discusses dissolution testing of pharmaceutical products. It defines dissolution as the molecular solubilization of a drug through the breakdown of its crystal structure. Dissolution testing is used to assess drug release, meet regulatory requirements, develop formulations, ensure manufacturing consistency, and correlate in vivo and in vitro performance. Challenges include maintaining sink conditions for poorly soluble drugs. The main apparatuses described are baskets, paddles, rotating cylinders, and flow-through cells. Proper controls of temperature, medium, apparatus, and sampling are also discussed.

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    The document discusses dissolution testing of pharmaceutical products. It defines dissolution as the molecular solubilization of a drug through the breakdown of its crystal structure. Dissolution testing is used to assess drug release, meet regulatory requirements, develop formulations, ensure manufacturing consistency, and correlate in vivo and in vitro performance. Challenges include maintaining sink conditions for poorly soluble drugs. The main apparatuses described are baskets, paddles, rotating cylinders, and flow-through cells. Proper controls of temperature, medium, apparatus, and sampling are also discussed.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    48 views17 pages

    USB Disolusi

    Uploaded by

    lidha
    The document discusses dissolution testing of pharmaceutical products. It defines dissolution as the molecular solubilization of a drug through the breakdown of its crystal structure. Dissolution testing is used to assess drug release, meet regulatory requirements, develop formulations, ensure manufacturing consistency, and correlate in vivo and in vitro performance. Challenges include maintaining sink conditions for poorly soluble drugs. The main apparatuses described are baskets, paddles, rotating cylinders, and flow-through cells. Proper controls of temperature, medium, apparatus, and sampling are also discussed.

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    Course:

    Dissolution
    Syaiful Choiri, M.Pharm.Sci., Apt.

    Pharmaceutical Technology and Drug Delivery


    Department of Pharmacy
    Dissolution
    • The dissolution phenomenon depicts the molecular
    solubilization of the drug through the breakdown of
    crystal-lattice structure.
    • On the other word, alteration of the solid state to
    the molecular dispersion in the medium is occurred.

    76
    Dissolution testing: do
    really need them?

    77
    Purposes of dissolution
    testing
    • To assess either the amount of drug released or the
    drug release profile
    • To fulfil the compendia requirements
    • To develop a formulation
    • To maintain the performance and consistency of the
    manufacturing processes
    • In vitro equivalency testing of drug release
    • In vivo in vitro correlation

    78
    Drug release phenomenon
    • The diffusion is mainly related to the dissolution
    phenomenon.
    • The diffusion phenomenon followed Fick’s rules
    (Fick II)

    δC (Cs − Cb)
    = DA
    δx h
    kT
    D=
    18πrη
    79
    Sink condition: a big
    challenge
    • The sink condition means the dissolution/diffusion
    rate of the drug is constant in which it is achieved
    by the greater ratio of medium volume to the
    saturated solubility of the drug in range of 10-20
    times
    • It is a big problem for a poorly water soluble drug
    with a high drug loading
    • The sink condition affects the gradient
    concentration between stagnant layer and bulk
    concentration

    80
    Dissolution in compendia
    procedure
    • Apparatus 1 (basket)
    • Apparatus 2 (paddle)
    • Apparatus 3 (rotating cylinder)
    • Apparatus 4 (flow through cell)
    • Apparatus 5 (paddle over disk)
    • Apparatus 6 (cylinder)
    • Apparatus 7 (reciprocating holder)

    81
    Apparatus 1 (Basket)

    83
    Apparatus 1 (Basket)
    • Suitable for capsule or tablet dosage form. In
    addition, beads and floating beads can be
    performed in this apparatus
    • Easy to pH change or medium stage dissolution
    procedure
    • Bubble in the basket wall inhibits the drug release
    • Dead zone i.e. no hydrodynamic movement of the
    medium below the basket

    84
    Apparatus 2 (Paddle)

    85
    Apparatus 2 (Paddle)
    • Suitable for tablet dosage form
    • Capsule dosage form needs sinker to avoid the
    tablet floating
    • Sinker can be made form inert material e.g. 316L
    wired 22/20G
    • No dead zone and full hydrodynamic movement
    • Although, the shifting of pH or pH stage dissolution
    procedure is not easy owing to disturbance of the
    drug release

    86
    Consideration for dissolution
    testing
    • Temperature should be controlled
    • Medium and volume, apparatus and aggitation,
    time sampling can be obtained from individual
    monograph

    87
    88
    Dissolution procedure of
    acyclovir tablet

    89
    Dissolution data calculation

    Let’s discuss it deeply

    90
    Dissolution data interpretation

    91

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