Dry Powder Capsule Coating to Prevent Moisture Agglomeration
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Solution Overview
Problem
Dry powder formulations for respiratory diseases like asthma and COPD face issues with moisture absorption by inhalation capsules, leading to reduced active agent delivery, agglomeration, and capsule deformation, which existing solutions do not adequately address.
Innovation Solution
The process involves dividing excipients into two fractions with different average particle sizes, where the finer fraction covers the capsule inner surfaces through vibration, preventing direct contact with the active agent and minimizing moisture absorption, ensuring the coarser fraction and active agent mixture is filled into covered capsules.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If capsules are made of traditional materials, then they are easy to manufacture, but they absorb moisture leading to agglomeration and deformation
Solution Approach 1:
The excipient is applied to the capsule inner surface in advance, before the active agent is introduced. This preliminary coating creates a protective barrier that prevents moisture absorption and agglomeration during storage, while allowing the capsule to be manufactured using traditional materials and methods.
Solution Approach 2:
The excipient acts as an intermediary substance between the capsule material and the active agent. It forms a protective layer on the capsule inner surface that mediates the interaction between moisture and the active agent, preventing direct contact and subsequent agglomeration.
2Device complexity
If excipient is mixed with active agent before filling, then filling process is simplified, but agglomeration occurs reducing active agent delivery
Solution Approach 1:
The formulation process is segmented into separate steps: first applying the excipient to the capsule, then introducing the active agent. This segmentation prevents premature mixing that would cause agglomeration, while maintaining a relatively simple overall process flow.
Solution Approach 2:
The excipient is preliminarily applied to the capsule before the active agent is introduced. This preliminary placement of the excipient creates a protective barrier that prevents agglomeration during the subsequent filling operation, ensuring precise active agent delivery.
3Strength
If moisture is absorbed by capsule, then capsule material becomes softer, but active agent adheres to capsule surface and agglomerates
Solution Approach 1:
The excipient serves as an intermediary layer between the capsule material and the active agent. Even when the capsule absorbs moisture and becomes softer, the excipient barrier prevents direct contact between the active agent and the moistened capsule surface, thereby preventing agglomeration.
Solution Approach 2:
The moisture absorption property of the capsule material, which normally causes harm through agglomeration, is converted into a benefit. The excipient layer allows the capsule to absorb moisture without transferring this harm to the active agent, effectively protecting the formulation while utilizing the capsule's inherent properties.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach effectively prevents agglomeration, maintains capsule stability, ensures precise delivery of the active agent, and maintains the required amount of the active agent, enhancing the pharmaceutical quality and stability of the dry powder formulation.
Implementation Method 1
the capsules containing the finer excipient fraction is subjected to vibration and particles of the excipient are ensured to cover the inner surfaces of the capsules
Implementation Method 2
the excipients in the formulation enable to carry the active agents to the respiratory tract of the patient since they adsorb the active agents to their surfaces
Data Source
AI summary
The present invention relates to a process developed for production of a dry powder medicament used in respiratory tract diseases such as asthma and COPD.