Lenalidomide Tablet Coating for Swallowing and Leakage Control

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Solution Overview

Problem

The existing hard capsule formulations of lenalidomide are inconvenient for patients due to their bulky size and shape, which can cause swallowing difficulties and exposure risks, and they lack adequate coating to prevent drug leakage during handling.

Innovation Solution

A tablet composition of lenalidomide with a sufficient coating layer, comprising a combination of diluents, disintegrants, and lubricants, designed to mimic the dissolution pattern and release rate of the capsule form, ensuring bioequivalence and physicochemical equivalence while providing improved handling and safety through a thicker coating that shields the drug.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If hard capsule formulation is used, then drug protection is achieved, but the capsule is bulky and inconvenient for patients to take

Engineering Contradiction:

Improveease of takingVSAvoidcapsule size

Core Design Contradiction:

Ease of operationVSVolume of moving object

Solution Approach 1:

The patent changes the physical form parameter from capsule to tablet, and further optimizes the tablet size parameters (length not exceeding 1.5 times the diameter, diameter 5-20mm) to achieve a compact shape that is easier to swallow while maintaining drug protection

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If hard capsule formulation is used, then drug protection is achieved, but the capsule may stick to throat or esophagus during swallowing

Engineering Contradiction:

Improveease of takingVSAvoidthroat sticking

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent changes the dosage form from capsule to tablet with optimized dimensions (length not exceeding 1.5 times the diameter, diameter 5-20mm), creating a smaller, more manageable form that reduces the risk of sticking to throat or esophagus during swallowing

Inventive Principle:

Principle #35Parameter changes

3Ease of manufacture

If uncoated tablet is used, then manufacturing simplicity is achieved, but drug exposure risk to handlers increases

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoiddrug exposure risk

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies a coating layer (thin film) on the tablet surface that acts as a barrier to prevent drug exposure to handlers while maintaining manufacturing feasibility. The coating provides protective shielding without significantly complicating the manufacturing process

Inventive Principle:

Principle #30Flexible shells and thin films

4Object-affected harmful factors

If tablet coating is applied, then drug exposure prevention is achieved, but coating may be insufficient due to low coating rate

Engineering Contradiction:

Improvedrug exposure preventionVSAvoidcoating uniformity

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent employs a coating process that forms a protective film on the tablet surface. The coating layer, even at thin depths, provides sufficient drug shielding while the process parameters are controlled to achieve adequate coating uniformity for safety purposes

Inventive Principle:

Principle #30Flexible shells and thin films

5Ease of operation

If tablet form is developed, then handling convenience is improved, but drug leakage risk during handling increases

Engineering Contradiction:

Improvehandling convenienceVSAvoiddrug leakage risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies a coating layer on the tablet that serves as a protective barrier, preventing drug leakage during handling while maintaining the tablet's compact and convenient form factor for patient use

Inventive Principle:

Principle #30Flexible shells and thin films

Data Source

PatentUS11077099B2Oral tablet formulation of lenalidomide

Publication Date: 2021.08.03 SAMYANG HLDG CORP

AI summary

The present disclosure relates to an oral tablet composition comprising lenalidomide and a method for preparing the same. More particularly, the present disclosure relates to a tablet-type composition and a method for preparing the same wherein the composition exhibits physicochemical equivalence with lenalidomide preparations of hard capsules, has the same pharmacological, therapeutic effect in non-clinical studies and bioequivalence studies, and also has improved ease of taking, handling, safety and the like.