Coated API Sieving and Aeration Control
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Solution Overview
Problem
Existing pharmaceutical compositions face challenges in stabilizing the disintegration time and dissolution rate of API-coated particles due to agglomeration of coating materials and aeration in pharmaceutical suspensions, which can lead to poor dose weight accuracy and content uniformity.
Innovation Solution
The proposed solution involves coating the API with a water insoluble material like wax and a second coating material such as silica, without the need for water soluble or swellable materials. This coating process minimizes agglomeration by removing excess coating material through sieving and incorporates terpene-based compounds to reduce aeration in pharmaceutical suspensions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If water soluble or swellable materials are used in the coating, then the coating can be applied easily, but agglomeration of coating materials occurs leading to poor disintegration time stability and dissolution rate
Solution Approach 1:
The patent changes the fundamental parameter of coating material solubility from water-soluble/swellable to water-insoluble. This parameter change eliminates the agglomeration issue that occurs with water-soluble materials while maintaining coating applicability through alternative methods such as spray drying or fluid bed coating with non-aqueous solvents.
Solution Approach 2:
The patent employs composite coating materials comprising water-insoluble polymers combined with specific additives that prevent agglomeration. The composite structure provides both the coating functionality and the anti-agglomeration properties needed for stable disintegration and dissolution characteristics.
2Device complexity
If excess coating material is not removed, then the coating process is simpler, but agglomeration increases leading to poor dose weight accuracy and content uniformity
Solution Approach 1:
The patent implements a separation step that extracts and removes excess coating material from the coated API particles. This is achieved through techniques such as fluid bed separation, centrifugation, or filtration, which effectively separate the coated particles from unadhered coating material, thereby improving dose weight accuracy and content uniformity.
Solution Approach 2:
The patent changes the physical parameters of the coating material to enable effective separation. By using water-insoluble materials with specific particle size distributions and densities, the patent creates conditions where excess coating material can be readily separated from coated particles through physical separation methods.
3Ease of manufacture
If aeration is not controlled in pharmaceutical suspensions, then the suspension preparation is simpler, but aeration occurs leading to poor dose weight accuracy and content uniformity
Solution Approach 1:
The patent introduces an intermediary substance or modification to the suspension system that mediates between the coating particles and the suspension medium. This intermediary prevents aeration during suspension preparation while maintaining the simplicity of the process. It may involve surfactants, viscosity modifiers, or specific suspension formulations that prevent air entrapment.
Solution Approach 2:
The patent changes the physical parameters of the pharmaceutical suspension such as viscosity, density, or composition to prevent aeration. By adjusting these parameters, the suspension becomes less prone to air entrapment during mixing and processing, thereby improving content uniformity without significantly complicating the preparation process.
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
The approach effectively stabilizes the disintegration time and dissolution rate of API-coated particles, improving the shelf life and ensuring consistent dose weight accuracy and content uniformity in pharmaceutical compositions.
Implementation Method 1
an inactive ingredient may be used to mask the taste of the API by wet coating or dry coating the API particle to produce a functional coating surrounding the API particle such that it prevents API release in the mouth
Implementation Method 2
mechanical and/or thermal energy applied to the combination of the API, first coating material, and second coating material
Implementation Method 3
mechanical and/or thermal energy applied to the combination of the API, first coating material, and second coating material
Implementation Method 4
incorporates terpene-based compounds to reduce aeration in pharmaceutical suspensions
Implementation Method 5
removing excess coating material through sieving
Implementation Method 6
a hydrophobic coated API particle can be placed in a matrix solution/suspension to form a pharmaceutical suspension
Data Source
AI summary
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising coated API. Excess coating material that is not bound to coated API may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Additionally, the compositions can be formulated to preserve the functional coating of coated API and to minimize aeration of API when mixed into suspension.