Multiparticulate Tamsulosin and Dutasteride Capsule Formulation

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Solution Overview

Problem

Current pharmaceutical compositions of Tamsulosin and Dutasteride are complex, time-consuming, and expensive to develop, with a lack of simple, cost-effective technologies for combining these drugs in a single unit multiparticulate capsule dosage form.

Innovation Solution

A process for preparing multiparticulate formulations of Tamsulosin and Dutasteride involving the preparation of inner cores, modified release coatings, and sequential seal coatings to create a stable and efficient capsule or tablet form, where Tamsulosin and Dutasteride are physically separated and coated within a hard gelatin capsule.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If capsule technology is used to combine Tamsulosin and Dutasteride in marketed formulations (JALYN, COMBODART), then effective drug delivery is achieved, but the formulation process becomes complex, time-consuming and expensive

Engineering Contradiction:

Improveeffective drug deliveryVSAvoidformulation process complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The formulation is divided into separate functional components: Tamsulosin hydrochloride pellets providing sustained release, and Dutasteride soft gelatin capsules providing immediate release. This segmentation allows each drug to be optimized independently while maintaining effective delivery, resolving the contradiction between reliability and complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The Dutasteride soft gelatin capsules are nested within the hard gelatin capsule that also contains Tamsulosin sustained release pellets. This nested structure enables both drugs to be delivered through a single capsule unit, achieving effective combined drug delivery without requiring complex multi-step formulation processes.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If capsule technology is used to combine Tamsulosin and Dutasteride in marketed formulations, then effective drug delivery is achieved, but development time and costs increase

Engineering Contradiction:

Improveeffective drug deliveryVSAvoiddevelopment time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The Tamsulosin is pre-formulated as sustained release pellets and Dutasteride is pre-formulated as soft gelatin capsules before being combined in the final capsule. This preliminary action allows each component to be optimized and tested separately, reducing overall development time while maintaining effective drug delivery.

Inventive Principle:

Principle #10Preliminary action

3Duration of action of moving object

If physically separated Tamsulosin and Dutasteride units are present in a single capsule, then modified release profiles are achieved, but formulation complexity increases

Engineering Contradiction:

Improvemodified release profilesVSAvoidformulation structure

Core Design Contradiction:

Duration of action of moving objectVSDevice complexity

Solution Approach 1:

Different release profiles are achieved by using different physical forms and release mechanisms for each drug: Tamsulosin in sustained release pellets and Dutasteride in immediate release soft gelatin capsules. This local quality approach allows modified release profiles without requiring complex overall formulation structure.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS11771691B2Pharmaceutical composition of Tamsulosin and Dutasteride

Publication Date: 2023.10.03 ZIM LAB LTD

AI summary

The present invention relates to a novel pharmaceutical composition of Tamsulosin and Dutasteride and process of manufacture thereof. Specifically, the present invention relates to multiparticulate(s) of Tamsulosin and Dutasteride filled in capsule or/compressed in tablet dosage form and process of manufacture thereof.