FMOA Tablet Composition for Iron Deficiency Treatment
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Solution Overview
Problem
Current formulations of ferrimannitol-ovalbumin (FMOA) face challenges in creating solid dosage forms due to its metallic taste and handling difficulties, leading to unpleasant liquid forms and granular compositions that are hard to swallow and prone to emesis, especially in pregnant women.
Innovation Solution
Development of oral pharmaceutical tablets comprising granules of FMOA with intragranular and extragranular excipients, including binders and fillers, allowing for fast disintegration and dissolution, and optional coating to create a pleasant taste and robust manufacturing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If FMOA is formulated as liquid dosage forms to mask metallic taste, then taste is improved, but ease of operation deteriorates due to emetic events and patient intolerance
Solution Approach 1:
The patent changes the physical state parameter from liquid to solid (tablets), transforming the dosage form to eliminate metallic taste while maintaining patient tolerance. The tablets are designed to disintegrate rapidly in the mouth, releasing FMOA in a controlled manner that avoids the emetic effects associated with liquid formulations.
Solution Approach 2:
The patent introduces tablets as an intermediary dosage form between liquid and solid. The tablets contain FMOA embedded in a matrix that controls its release, acting as a mediator that masks the metallic taste during storage and administration while releasing the active ingredient in a patient-tolerable manner upon contact with saliva.
2Ease of operation
If FMOA is formulated as solid dosage forms (tablets) to avoid metallic taste and improve patient intake, then ease of operation is improved, but manufacturing precision deteriorates due to handling difficulties of FMOA
Solution Approach 1:
The patent applies preliminary action by pre-processing FMOA through granulation before tablet formation. The FMOA is first granulated with excipients to create uniform granules with consistent size and composition, which then serve as the basis for tablet manufacturing. This preliminary granulation step ensures uniform distribution of FMOA and eliminates handling difficulties associated with raw FMOA powder.
Solution Approach 2:
The patent uses composite materials by combining FMOA with various excipients (binders, fillers, disintegrants, lubricants) in specific ratios to create a composite granule system. This composite approach allows the formulation to maintain dosage uniformity while accommodating the handling characteristics of FMOA. The granulation process creates a composite structure where FMOA is distributed uniformly within the matrix of excipients.
3Manufacturing precision
If FMOA is formulated as granular composition to simplify manufacturing, then manufacturing precision is improved, but ease of operation deteriorates due to difficulty in swallowing and emetic events
Solution Approach 1:
The patent changes the physical form parameter from granular to tablet, transforming the dosage form to improve swallowability. The tablets are designed with appropriate size, shape, and weight parameters that make them easy to swallow, while maintaining the manufacturing simplicity of granular formulations through the use of standard tablet compression equipment and processes.
Data Source
AI summary
The invention refers to an oral pharmaceutical tableted dosage form which comprises a mixture of: a) granules comprising ferrimannitol-ovalbumin (FMOA) and at least an intragranular pharmaceutical acceptable excipient including a binder; and b) extragranular pharmaceutical excipients including a filler and a binder; which may be obtained by wet-granulation and compression.