Granular Pharmaceutical Formulation for Oral Straw Administration
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Solution Overview
Problem
Existing pharmaceutical formulations for oral administration through straws face challenges in efficient delivery due to high vacuum pressure requirements and large liquid volumes needed, as well as issues with particle agglomeration and incomplete delivery.
Innovation Solution
A pharmaceutical formulation comprising granules with a core of active pharmaceutical ingredients (API) coated with a first polymer layer and a second layer of sugar or sugar alcohol particles, formed using a high shear granulator, which reduces vacuum pressure and liquid volume requirements for ingestion and prevents agglomeration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional pharmaceutical formulations are used in straws, then high vacuum pressure and large liquid volumes are required for administration, but this increases the complexity and difficulty of delivery
Solution Approach 1:
The patent changes the physical parameters of the pharmaceutical formulation by coating API particles with sugar or sugar alcohol particles, creating a granular structure with specific size distribution (0.1-2.0 mm). This parameter change reduces the vacuum pressure requirement from conventional high levels to below -50 mbar, making administration easier and more controlled.
Solution Approach 2:
The patent creates a composite granular formulation where sugar or sugar alcohol particles are coated onto API particles. This composite structure combines the medicinal properties of the API with the flow and dissolution characteristics of sugar/sugar alcohol, resulting in a formulation that requires lower vacuum pressure and smaller liquid volumes for administration.
2Reliability
If conventional pharmaceutical formulations are used in straws, then large liquid volumes are required for complete delivery, but this increases the volume and complexity of the delivery system
Solution Approach 1:
The patent changes the particle size parameters of the formulation to 0.1-2.0 mm through sugar/sugar alcohol coating, which optimizes the balance between complete delivery and liquid volume. This parameter optimization ensures reliable complete delivery while reducing the required liquid volume from conventional large volumes to below 10 mL.
Solution Approach 2:
The patent uses sugar or sugar alcohol particles as a placeholder or carrier that replicates the volume and flow characteristics needed for complete delivery. These coating particles ensure that the API is fully delivered through the straw mechanism without requiring excessive liquid volumes, as the coated granules themselves facilitate the delivery process.
3Manufacturing precision
If particles are mixed in high shear granulator, then coating is formed on API particles, but particle agglomeration may occur
Solution Approach 1:
The patent optimizes the particle size parameters of the API cores before coating to 0.1-2.0 mm, and controls the coating layer thickness to 1-50 μm. These parameter changes ensure uniform coating distribution while preventing excessive agglomeration. The controlled particle size and coating thickness maintain individual particle identity while achieving the desired coating uniformity.
Solution Approach 2:
The patent segments the formulation into distinct components: API particles (0.1-2.0 mm), coating layer (1-50 μm), and inter-particle spaces. This segmentation prevents complete agglomeration by maintaining physical separation between particles while allowing controlled coating formation. The segmented structure ensures manufacturing precision in coating uniformity while preventing instability from excessive agglomeration.
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 formulation allows for efficient oral administration with lower vacuum pressure and reduced liquid volume, ensuring complete delivery of the API and preventing straw clogging, as evidenced by scanning electron microscopy showing a rough surface with adhered primary particles.
Implementation Method 1
Coalescence, on the other hand, involves the collision and sticking together of two granules, causing granules to grow rapidly. In a high-shear mixer, both coalescence and layering occur at the same time scale due to strong agitation by the impeler.
Implementation Method 2
Layering is the formation of a fresh layer of powder around an existing granule, causing slow growth.
Implementation Method 3
The formulation is considered to be 'in use in the straw' when a pressure gradient is applied along the length of the straw containing the formulation, e.g. by a person sucking on one end of the straw when the opposing end is inserted into a liquid.
Data Source
AI summary
The present invention relates to a pharmaceutical formulation suitable for use in a straw suitable for oral administration of said pharmaceutical formulation, wherein the pharmaceutical formulation is a granular solid comprising a core, an optional first coating layer, and a second coating layer. The present invention also relates to a straw suitable for oral administration of such a pharmaceutical formulation, the use of said pharmaceutical formulation in the treatment of a condition in a subject in need thereof, and a method for preparing said pharmaceutical composition.