Ivermectin Soft Gelatin Capsule Lipid Formulation

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Solution Overview

Problem

Ivermectin's insolubility and instability in aqueous environments pose challenges for formulating stable and bioavailable oral soft capsule formulations, leading to poor absorption and bioavailability, especially when administered with food.

Innovation Solution

A formulation using a lipid medium with medium chain triglycerides, a surfactant, and a co-surfactant, along with an antioxidant, to create a self-emulsifying system that enhances solubility and stability, allowing for effective bioavailability and rapid absorption of Ivermectin in soft capsules.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If Ivermectin is formulated in aqueous media, then it can be administered orally, but its absorption is poor and bioavailability is low

Engineering Contradiction:
Improveoral administrationVSAvoidbioavailability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the physical-chemical parameters of the formulation medium from aqueous to lipid-based (medium chain triglycerides), which fundamentally alters the solubility characteristics of Ivermectin and enables effective absorption while maintaining oral administration route

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces surfactants and co-surfactants as intermediary substances that facilitate the interaction between the lipid medium and the gastrointestinal environment, enabling proper absorption of Ivermectin while maintaining formulation stability

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If Ivermectin is formulated in soft capsules, then it provides convenient oral delivery, but its instability in aqueous environments compromises formulation stability

Engineering Contradiction:
Improvesoft capsule formulationVSAvoidformulation stability
Core Design Contradiction:
Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent changes the chemical environment from aqueous to lipid-based (medium chain triglycerides), which eliminates hydrolysis and oxidation reactions that cause Ivermectin degradation, thereby ensuring formulation stability in soft capsules

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The lipid medium creates an inert chemical environment that protects Ivermectin from degradation by water, oxygen, and other reactive species, maintaining formulation stability throughout shelf life

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

3Adaptability or versatility

If Ivermectin is administered with food, then it can be taken at any time, but absorption is hindered and bioavailability decreases

Engineering Contradiction:
Improveflexible timingVSAvoidabsorption
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent changes the formulation from water-soluble to lipid-soluble (medium chain triglycerides), which enables Ivermectin to be absorbed effectively regardless of food presence, as the lipid medium is not interfered with by dietary components

Inventive Principle:
Principle #35Parameter changes

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 ensures increased bioavailability and stability of Ivermectin, enabling its absorption at any time without food interference, with improved solubility and reduced risk of impurity formation, thus providing a stable and effective oral delivery system.

Implementation Method 1

A formulation using a lipid medium with medium chain triglycerides, a surfactant, and a co-surfactant, along with an antioxidant, to create a self-emulsifying system that enhances solubility and stability

Methodology Applied
Scientific EffectEmulsification: Emulsion

Implementation Method 2

an antioxidant agent, to form a soft capsule for oral administration

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Data Source

PatentUS20230405034A1Formulation of ivermectin in soft gelatin capsules
Publication Date: 2023.12.21 PROCAPS

AI summary

The present invention relates to a formulation of Ivermectin in soft capsules. In particular, the present invention relates to a formulation of Ivermectin in soft capsules which allows proper absorption in water, allowing the drug to be consumed at any time. Ivermectin, as an insoluble active ingredient, according to the invention, can be formulated in a liquid solution without compromising its stability and without creating impurities to form a suitable soft gelatin capsule. Therefore, the invention comprises a formulation comprising Ivermectin in a lipid medium which includes a surfactant in combination with an oily solvent, a co-surfactant and an oxidant, to form a soft capsule comprising a collagen coating, a plasticiser and gelatin. The field of the invention relates to improving the bioavailability of insoluble drugs such as Ivermectin for delivery in oral soft gelatin capsule forms.