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    Home > Medical News > Medical Research Articles > Make production easier and make tablets better

    Make production easier and make tablets better

    • Last Update: 2021-07-31
    • Source: Internet
    • Author: User
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    In the process of R&D and production, we sometimes encounter some seemingly contradictory demands that are actually "just needed", such as requiring both high drug loading and small size of the tablet; both the tablet has sufficient hardness and the requirement for it.
    Fast disintegration; not only want more space for formula design, but also want less variety of auxiliary materials; not only want to loose and not harsh production conditions, but also want to improve production efficiency and quality

    .
    With the development of pharmaceutical excipients, these demands are actually no longer a problem, but how to realize these demands quickly and well is still our tireless pursuit

    .

    The SPI mannitol Mannogem ® XL Opal that we are going to show you today is a spray-dried direct pressure mannitol that can well achieve the above requirements.
    Its particle size is 160μm, which meets NF, EP, JP and CP requirements are basically the same as the standard spray-dried direct pressure mannitol on the market, but with better compressibility and disintegration, it can be well applied to existing formulas or innovative formulas

    .

    Performance analysis

    1.
    Particle size distribution


    2.
    Tensile strength and friability

    Test conditions: 500mg tablets 88% mannitol, 10% paracetamol (300μm particle size), 2% lubricant GP-8 rotary tablet machine test results are shown in Figure 2, Figure 3
    .


    3.
    Disintegration performance and release force

    Test conditions: 500mg tablets 88% mannitol, 10% paracetamol (300μm particle size), 2% lubricant GP-8 rotary tablet machine test results are shown in Figure 4, Figure 5
    .


    It can be seen from the test results that Mannogem ® XL Opal has the following advantages:

    ① It is a general excipient

    • High compressibility, high solubility, high hardness and low resilience

    ② Excellent disintegration performance, no disintegrant is needed
    • Disintegration speed increased by 20-30%

    ③ Lower ejection power
    • Less lubricant required-will increase hardness, disintegration properties and sensory feel

    • Conducive to scale-up and production

    Four, a broad formula design space

    Mannogem ® XL Opal can produce tablets that meet the hardness requirements in a large span of pressure range, with good production adaptability and easy replacement of equipment, thus having a broader space for formulation design
    .
    • Low friability
    • Higher tensile strength
    • Achieve rapid disintegration of high-hardness formulations
    • Lower stripping force can achieve higher production capacity


    Case analysis of paracetamol orally disintegrating tablets

    1.
    Drug loading, tensile strength and friability

    Test conditions:

    500mg tablets

    Drug = 300μm acetaminophen (poor compressibility)

    Prescription: 88% mannitol, 10% paracetamol API, 2% lubricant

    GP-8 Rotary Tablet Press


    test results:


    Use MannogemXL Opal's high-hardness ODT tablets with high API drug loading
    .

    • XL Opal has superior high drug loading capacity

    • XL Opal has higher tensile strength and lower friability

    Under any API drug loading used in the experiment, the mannitol/starch co-processed ODT formulation did not reach the target friability
    .

    2.
    Can it be used alone

    Test conditions:

    500mg tablets

    Group 1: Co-processing of mannitol starch (10-78% mannitol content), 10% acetaminophen (particle size 300μm), 10% MCC, 2% lubricant;

    Group 2: 10-88% mannitol XL Opal, 10% paracetamol, 2% lubricant;

    GP-8 Rotary Tablet Press

    The test results are shown in Figure 8 and Figure 9
    .



    Mannogem ® XL Opal can provide tablet formulations with sufficient hardness without the support of other auxiliary materials; competing products need to add 10% MCC to the formulation to meet the tablet requirements; competing products cannot achieve the target friability and hardness
    .


    3.
    Formula of acetaminophen orally disintegrating tablets

    Test conditions:

    500mg tablets

    Drug = 300μm acetaminophen (poor compressibility)

    86% mannitol, 10% acetaminophen API, 2% crospovidone, 2% lubricant

    GP-8 Rotary Tablet Press


    test results:





    From the above test results, it can be seen that Mannogem ® XL Opal can be used to prepare preparations that meet the requirements of orally disintegrating tablets; the preparations using competing mannitol-starch co-processed products have failed due to capping problems
    .
    It can be seen that using XL Opal can shorten the development time and increase the success rate

    .

    Summarize


    Mannogem ® XL Opal has the same physical properties as the standard spray-dried mannitol used on the market, but the performance is enhanced
    .

    The superior performance of XL Opal is reflected in:

    ① Higher tensile strength

    ② Higher active ingredient carrying capacity

    ③ Shorten the development cycle and increase the production speed, and increase the success rate

    • Improve the yield of problem prescriptions-reduce capping and fragility related problems

    • Broad formula design space

    • Smaller stripping force can increase production capacity

    ④ Speed ​​up the development of ODT formula
    • Fewer auxiliary materials are needed to accelerate development at a lower cost

    • Shorten the disintegration time limit to reach the target disintegration time

    • No need for a lot of additional adhesive

    ④ Improve patient compliance

    • Faster disintegration, better patient compliance and sensory experience

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