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    Pilot Plant Capsules Tablets ES

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    sakumar5678
    This document discusses techniques for scaling up production of capsules and liquid orals from a pilot plant to full production. For capsules, it covers the materials used including different types of gelatin, plasticizers, colorants and opacifying agents. It describes the manufacturing processes for hard shell and soft gel capsules. For liquid orals, it discusses tank selection, mixing, filtration, filling, and preservative evaluation during the scale-up process. Proper control of parameters like temperature, humidity and cleaning procedures is important to ensure quality during manufacturing and storage of capsules and oral liquids at production scale.

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    Pilot Plant Capsules Tablets ES

    Uploaded by

    sakumar5678
    21 views32 pages
    This document discusses techniques for scaling up production of capsules and liquid orals from a pilot plant to full production. For capsules, it covers the materials used including different types of gelatin, plasticizers, colorants and opacifying agents. It describes the manufacturing processes for hard shell and soft gel capsules. For liquid orals, it discusses tank selection, mixing, filtration, filling, and preservative evaluation during the scale-up process. Proper control of parameters like temperature, humidity and cleaning procedures is important to ensure quality during manufacturing and storage of capsules and oral liquids at production scale.

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    Pilot Plant Capsules Tablets ES

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    This document discusses techniques for scaling up production of capsules and liquid orals from a pilot plant to full production. For capsules, it covers the materials used including different types of gelatin, plasticizers, colorants and opacifying agents. It describes the manufacturing processes for hard shell and soft gel capsules. For liquid orals, it discusses tank selection, mixing, filtration, filling, and preservative evaluation during the scale-up process. Proper control of parameters like temperature, humidity and cleaning procedures is important to ensure quality during manufacturing and storage of capsules and oral liquids at production scale.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    21 views32 pages

    Pilot Plant Capsules Tablets ES

    Uploaded by

    sakumar5678
    This document discusses techniques for scaling up production of capsules and liquid orals from a pilot plant to full production. For capsules, it covers the materials used including different types of gelatin, plasticizers, colorants and opacifying agents. It describes the manufacturing processes for hard shell and soft gel capsules. For liquid orals, it discusses tank selection, mixing, filtration, filling, and preservative evaluation during the scale-up process. Proper control of parameters like temperature, humidity and cleaning procedures is important to ensure quality during manufacturing and storage of capsules and oral liquids at production scale.

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    © All Rights Reserved
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    Download as ppt, pdf, or txt
    of 32

    PILOT PLANT SCALE-UP

    TECHNIQUES FOR CAPSULES


    AND LIQUID ORALS

    By: Praful Joshi

    Production considerations for


    Capsules:
    Materials
    Method of production
    Filling equipment

    Materials:
    Gelatin
    Plasticizers

    Colorants
    Opacifying agents
    Preservative
    Water

    Plasticizer:
    -

    Plasticizer used glycerin or sorbitol

    5-10% is used in hard gelatin shell

    10-15% is used in soft gelatin shell

    Colorants:
    -

    Soluble dyes

    Insoluble dyes

    Opacifying Agents:

    Titanium Dioxide (0.5%)

    Water:

    Hot de-mineralized water is used in the preparation of dipping

    solution.

    Method of production of
    Gelatin:
    Type A:
    By acid hydrolysis: exhibits isoelectric
    point at pH 9.0 Firmness
    Type B:
    By
    alkaline hydrolysis: exhibits
    isoelectric point at pH 4.7 Plasticity

    Method of production of
    Gelatin:
    Mixture of both the types of gelatin is used for

    capsule manufacturing process reason being


    availability and cost considerations
    Iron content in gelatin should not be more
    than 15ppm if greater than 15ppm then it
    reacts with color, shell and product
    Gelatin viscosity should be 38 +/- 2 mps

    Type A Acid Hydrolysis:


    Pork skin
    Washed
    1%-5% HCl
    10-30 hours
    Acid removed
    hot water extraction
    Filter and vacuum
    concentrated

    Cooled to solidify
    Air dry
    Mill to size

    Type B Alkaline Hydrolysis:


    Method-1:
    Dry bone or bone meal
    Dicalcium phosphate and 5% HCl
    10-15 days

    10% Lime
    4-8 weeks
    Lime removal
    pH adjustment
    Hot water extraction
    Filter
    Vacuum concentration

    Cooled to solidify
    Air dry
    Mill to size

    Type B Alkaline Hydrolysis:


    Method-2:
    Calf skin
    Wash
    10% Lime
    6-12 weeks
    Water wash
    10-30 hours

    Hot water extraction


    Filter
    Vacuum
    concentration

    Cooled to solidify
    Air dry
    Mill to size

    Manufacture of Hard Gelatin Capsules:

    FFS Technology (Form Fill Seal)


    Dipping
    Spinning
    Drying

    Stripping
    Trimming
    Joining

    Manufacturing of Hard Gelatin Capsules:


    Gelatin gel of
    Controlled viscosity is taken
    Pins dipped for a particular
    period of time

    Gel sticks to the pin

    Pins are spun for uniform


    distribution of gel
    Pins passed through
    Drying chamber
    Gel solidifies and is stripped
    (removed)
    Gel trimmed to particular length
    (Body and Cap)

    Joining of cap to body

    Encapsulation of Hard gelatin


    capsules:
    To produce capsules on high speed equipment, the

    processed powder blend must have the proper particle


    size distribution and bulk density required to promote
    good flow characteristics and to result in the formation of
    compacts of the right size and sufficient cohesiveness to
    be filled in the capsules
    Physical properties - Bulk density, powder flow
    characteristics
    Chemical Properties - prolonged trials of many hours
    using multiple batches are required for a process can be
    judged as acceptable for routine production
    The size and types of equipment may affect
    the
    granulation properties

    Manufacture of Soft Gelatin Capsules:

    Gelatin gel gelatin + plasticizer + water


    Maintained at a particular temperature to remain as gel.
    2 hoppers fill contents and gelatin (high temperature (930C)

    molten state flows easily)

    Manufacture of Soft Gelatin Capsules:

    Gel passed between two compression roles (having depressions)

    at cold temperature for solidification of gelatin


    After gelatin is solidified gelatin ribbons are formed with
    depressions and contents are filled into these depressions

    Manufacture of Soft Gelatin Capsules:

    After the contents are filled sealing of the shells is done between

    370C and 400C


    Liquids should be filled at gravity at 350C
    Oils, suspensions and semisolids can be encapsulated

    Size of Capsules:
    20 minim oblong
    16 minim oval

    9 minim round

    Filling equipments:
    Eli Lilly, Indianapolis, Indiana
    Parke-Davis, Detroit, Michigan
    Hofliger and Karg, Waiblingen, Stuttgart, Germany
    mG2 Macchine Automatiche, Pianoro, Italy
    Fratelli Zanasi, Bologna, Italy
    Cap-Fill Products, Ardmore, Pennsylvania
    Dott Bonapace, Milano, Italy
    Abbott Laboratories, North Chicago, Illinois
    Hoffmann-La Roche, Nutley, New Jersey

    Filling operations:
    Empty capsules
    Formulation
    Finishing

    Special Techniques Imprinting, Sealing,

    Capsule locking

    Processing conditions:
    Humidity

    and temperature should be


    controlled during manufacturing and storage
    High Humidity swelling of capsule shells,
    dimension increases
    Low Humidity shrinking of capsule shells,
    brittle and dimension decreases
    High temperature degradation of capsule
    shells

    Evaluation of Capsules:
    Following are the tests that should be carried out
    for evaluation of the capsules

    Uniformity of weight
    Content of the active ingredients in the

    capsules
    Disintegration Test
    Dissolution

    Test

    Production considerations in
    Liquid Orals:
    Tank Selection
    Mixing and Dispersion
    Filtration and Clarification
    Transfer and Filling

    Preservative Evaluation

    Tank Selection:
    Depends on size, shape, working capacity
    and construction
    Material used for tank construction should
    not affect physical or chemical stability
    Glass-lined tanks are not used possibility of
    breakage and thus contaminating the
    product
    Magnetic SS interiors are used since particles
    resulting from abrasion can be extracted
    from the bulk liquid by in-line magnets

    Tank Selection:

    Adequate clean-up procedures developed


    Valve assembly to be examined for complete drainage
    For viscous liquids and suspensions flush bottom valves are

    used to avoid dead spots

    Mixing and Dispersion:

    Mixing of wide variety of vehicles, suspending

    agents, emulsifying agents, thickening agents


    and flavoring agents employed in liquid
    products makes the evaluation of mixing
    equipment an important parameter in pilot
    operation
    Insertion of tank baffles or reduction in
    agitation speed are used in case of air
    entrapment during mixing of viscous liquids

    Filtration and Clarification:

    Filtration an important parameter for ensuring the clarity in

    the scale-up products


    Pressurized filtration depending upon the viscosity, volume
    and rate requirements

    Transfer and Filling:

    Filling important parameter in the transfer of liquids from

    tank to tank and into containers


    New batches should not be started until the previous batches
    are completely emptied from the tanks.

    Preservative Evaluation:

    Preservative evaluation should be done in

    addition to physical and chemical tests


    Depending on the nature of the product and
    degree of protection required carbon dioxide
    or nitrogen can be overlaid during filling or
    holding stages.
    Bacteriological testing should be done, to know
    if the concentration of preservative is to be
    increased in the formulation

    References:
    The Theory and Practice of Industrial Pharmacy 2nd Edition
    by Lieberman and Lachman
    Pharmaceutical Sciences by Remington
    Pharmaceutical Sciences by Cooper
    Pharmaceutical Sciences by Tucker and Hayes
    Pharmaceutical Sciences by Tucker and Rednick

    Thank you
    Seminar on Pilot Plant Scale-Up Techniques for Capsules and
    Liquid Orals By Praful Joshi
    Faculty: Dr. Bijaya Ghosh

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