Zinc Histidine Tablet Composition for Dissolution and Color Stability
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Solution Overview
Problem
Existing zinc histidine formulations, particularly in tablet form, suffer from solubility decreases and discoloration during storage due to the use of excipients like lactose, making them unsuitable for compact administration forms.
Innovation Solution
Formulations containing zinc histidine or its solvate with excipients such as D-mannitol, sucrose, sorbitol, xylitol, corn starch, and crystalline cellulose, excluding lactose, fructose, and glucose, to maintain stability and solubility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lactose is used as an excipient in zinc histidine tablets, then the tablet can be formulated, but solubility decreases and discoloration occurs during storage
Solution Approach 1:
The patent removes lactose from the tablet formulation entirely and replaces it with alternative excipients (microcrystalline cellulose, mannitol, sorbitol, xylitol, starch) that do not cause discoloration or solubility degradation during storage
Solution Approach 2:
The patent changes the chemical composition parameters of the excipients used in the tablet, specifically substituting lactose with excipients having different chemical properties that are stable and do not interact adversely with zinc histidine during storage
2Ease of manufacture
If hard capsule form is used for zinc histidine, then formulation is simple, but ease of administration is poor due to large size
Solution Approach 1:
The patent segments the active ingredient zinc histidine into smaller tablet units that are easier to swallow and administer compared to large hard capsules, while maintaining the required dosage through proper formulation with excipients
3Reliability
If storage time is extended to three months under accelerated conditions, then stability is tested thoroughly, but dissolution rate decreases and discoloration increases
Solution Approach 1:
The patent selects excipients specifically designed to cushion and protect zinc histidine from degradation during extended storage under accelerated conditions (40°C, 75% RH), ensuring that dissolution rate remains above 80% and discoloration is minimized even after three months
Solution Approach 2:
The patent uses excipients like mannitol, sorbitol, and xylitol that are stable, non-reactive, and do not promote degradation over time, effectively acting as protective matrices that maintain tablet integrity and active ingredient stability during extended storage periods
Data Source
AI summary
A tablet comprising zinc histidine or a solvate thereof as an active ingredient, further comprising one or more ingredients selected from the group consisting of D-mannitol, sucrose, sorbitol, xylitol, corn starch, and potato starch; and crystalline cellulose; and excluding lactose, fructose, and glucose, and a tablet comprising zinc histidine or a solvate thereof as an active ingredient, having a 15-minute dissolution value of 80% or more in the paddle method (test solution: water, rotate speed: 75 rpm) (excluding lactose, fructose, and glucose), obtained by the following steps: granulating zinc histidine or a solvate thereof, one or more components selected from the group consisting of D-mannitol, sucrose, sorbitol, xylitol, corn starch, and potato starch, and crystalline cellulose, with a binder; drying the obtained granulate; and tableting the dried granulate.