Segmented Pharmaceutical Tablet for Accurate Partial Dosing

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Solution Overview

Problem

Current pharmaceutical tablets face issues with inaccurate or inconsistent dose division when broken, and combination dosage forms lack flexibility in adjusting the dose of one active ingredient without affecting the others, leading to imprecise dosing and potential loss of mass during splitting.

Innovation Solution

A method involving pharmaceutical tablets with multiple segments, where at least one segment contains a different concentration or absence of the drug, allowing precise breaking to achieve a partial dose, using a score or inactive segment to form tablettes with accurate dosing, and enabling flexible dose adjustment in combination products.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a tablet is broken to adjust the dose, then the dose can be modified, but the division is inaccurate or inconsistent

Engineering Contradiction:

Improvedose adjustmentVSAvoiddose accuracy

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The tablet is divided into multiple segments with different drug concentrations or compositions. Each segment can be broken off independently to achieve precise dose adjustments. The segmentation allows the tablet to be divided into predetermined portions with known drug amounts, eliminating the inaccuracy of random breaking.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different segments of the tablet have different local qualities, specifically different drug concentrations or compositions. This allows specific segments to be removed to achieve the desired dose while maintaining the integrity and accuracy of the remaining segments. The local quality variation enables precise dose control without affecting the entire tablet.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If a scored tablet is used to aid breaking, then the tablet can be more easily divided, but uneven breaking, chipping, or crumbling still occurs

Engineering Contradiction:

Improvetablet breakingVSAvoidbreaking uniformity

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The tablet contains pre-formed segmentation planes or weak planes that guide breaking. These internal segmentation features are more effective than surface scores, as they extend through the tablet body and ensure clean breaks along predetermined lines, preventing chipping and crumbling while maintaining breaking ease.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tablet is manufactured with pre-established breaking planes or separation layers during the compression process. This preliminary action creates predetermined fracture paths that guide the breaking process, ensuring uniform and clean separation without the need for deep surface scoring that causes chipping.

Inventive Principle:

Principle #10Preliminary action

3Adaptability or versatility

If combination dosage forms are used with homogeneous mixtures, then cost and compliance are improved, but the dose of individual active ingredients cannot be adjusted independently

Engineering Contradiction:

Improvedose flexibilityVSAvoiddosage form structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The combination tablet is segmented into distinct regions, each containing different active ingredients at specific concentrations. This segmentation allows independent dose adjustment of each active ingredient by removing specific segments, while maintaining the cost-effectiveness and compliance benefits of a single tablet formulation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the tablet have different local qualities in terms of drug composition and concentration. This enables selective removal of specific regions to adjust the dose of individual active ingredients independently, providing dose flexibility without requiring multiple separate tablets or complex delivery systems.

Inventive Principle:

Principle #3Local quality

4Quantity of substance

If a tablet is broken to provide a partial dose, then dose adjustment is achieved, but mass loss occurs due to crumbling or chipping

Engineering Contradiction:

Improvepartial doseVSAvoidmass loss

Core Design Contradiction:

Quantity of substanceVSLoss of substance

Solution Approach 1:

The tablet is manufactured with pre-formed separation planes or inactive segments that create clean break surfaces. This preliminary action ensures that when the tablet is broken, the fracture occurs along predetermined lines with minimal crumbling or chipping, thereby reducing mass loss and ensuring accurate dosing.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

An inactive segment or separation layer acts as an intermediary between the drug-containing segments. This intermediary facilitates clean breaking by providing a predetermined fracture plane that prevents direct stress concentration at the break point, thereby minimizing chipping and crumbling of the active drug segments.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS7713547B2Method of administering a partial dose of a segmented pharmaceutical tablet

Publication Date: 2010.05.11 ACCU BREAK TECHNOLOGIES INC

AI summary

A drug-containing pharmaceutical tablet adapted for accurate breaking which has two or more segments with at least one segment containing a drug.