Make production easier and make tablets better

Performance analysis

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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

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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

• Disintegration speed increased by 20-30%

• Less lubricant required-will increase hardness, disintegration properties and sensory feel

• Conducive to scale-up and production

Four, a broad formula design space

Case analysis of paracetamol orally disintegrating tablets

1.

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.

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
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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
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It can be seen that using XL Opal can shorten the development time and increase the success rate
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Summarize

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

• 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