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APPARATUS WITH TABLET BREAKDOWN IDENTIFICATION SYSTEM

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APPARATUS WITH TABLET BREAKDOWN IDENTIFICATION SYSTEM

ORDINARY APPLICATION

Published

date

Filed on 16 November 2024

Abstract

A friability testing apparatus for pharmaceutical tablets is disclosed, comprising a rotating drum for holding samples, a high-resolution imaging system for real-time tablet monitoring, and an AI-powered analysis module to detect tablet breakdown patterns. The system includes a user interface for displaying test progress and results, along with a control system to manage parameters. Additional features include automated sample loading, a variable-speed motor, vibration sensors for detecting anomalies, and a self-cleaning mechanism with air jets and UV sterilization. The AI module employs deep learning algorithms for precise analysis, while acoustic and calibration systems enhance performance. The method involves loading tablets, initiating tests, capturing and analyzing real-time images, and generating comprehensive reports with recommendations for formulation improvements. This apparatus offers advanced insights into tablet behavior, optimizing quality control and production processes in pharmaceutical manufacturing.

Patent Information

Application ID202411088776
Invention FieldCHEMICAL
Date of Application16/11/2024
Publication Number48/2024

Inventors

NameAddressCountryNationality
Dr. Madan Mohan GuptaNIMS University Rajasthan, Jaipur, Dr. BS Tomar City, National Highway, Jaipur- Delhi, Rajasthan 303121IndiaIndia

Applicants

NameAddressCountryNationality
NIMS University Rajasthan, JaipurNIMS University Rajasthan, Jaipur, Dr. BS Tomar City, National Highway, Jaipur- Delhi, Rajasthan 303121IndiaIndia

Specification

Description:The friability testing apparatus for pharmaceutical tablets 100 comprises a rotating drum 101 that is essentially the main element of this apparatus, which serves to determine the mechanical strength and durability of pharmaceutical tablet formulations based on simulated conditions of handling. The tumbling process simulates the effects of physical stresses that occur during transportation, packing, and delivery, giving essential insight into the resilience of the tablets under these stresses.

The apparatus comes with a high-resolution imaging system 102 that has a resolution high enough to capture images of the tablets in real-time during the test. There are high-speed cameras fitted on all sides of the drum to capture all-inclusive images from multiple angles and very slight cracks and defects when they occur. This information then undergoes analysis through an artificial intelligence-powered analysis module 103 that is used to classify the breakdown patterns of the tablets according to the captured images. AI Module is trained on large datasets of tablet images, the AI module identify different forms of damage, such as chipping, fragmentation, and erosion on the surface. It does this besides speeding up testing by automatically analyzing data and providing accurate and data-driven recommendations for tablet formulations.

A user interface 104 is available to provide real-time feedback on test progress and results, allowing operators to easily track ongoing tests. It is also be fitted with advanced functionality like an overlay from AR, which uploads information and alarms on a real-time image of the rotating drum 101, providing superior situational awareness. Management of all operational parameters such as rotational speed, camera configuration, and data acquisition is provided through a control system 105by ensuring the apparatus works for any of the testing conditions. The apparatus also carries remote access capability, for added flexibility. With this feature, authorized personnel monitor and control the testing from various off-site locations.

The friability apparatus offers advanced features of superior testing accuracy and reproducibility. A variable speed motor 107 drive the rotating drum 101 in variations of accordance with test parameters or in response to actual behavior of the table on real-time. The transparent drum makes it possible to have a direct view of the tablets for visual inspection as the test progresses. The system also allows for sample loading through automated processes and sample collection to support accurate handling of the samples by counting the tablets accurately prior to loading and then collecting them after the test is done in order to weigh and analyze them.

It contains an environmental simulation chamber in order to test the tablets under conditions that simulate real-world elements such as temperature and humidity. The acoustic analysis system 111 captures sound that are emanating during the test, while the thermal imaging camera tracks the increase and reduction in the tablets' temperatures, which signifies potential degradation.

The equipment is designed to self-clean via use of high-pressure air jets and UV sterilization, hence keeping it clean and free of contamination. All calibration routines are automated, eliminating the chance of errors brought about by the duration of use. Sensors that comprise electrostatic charge monitors and vibration detectors protect it from abnormal movements or static buildup in the case of malfunction.

For throughput applications, the test apparatus offers a continuous flow mode of testing, so that testing run for longer periods without having to feed and remove tablets. Nano-surface imaging of the tablets is captured on high-resolution maps both before and after testing to identify valuable microstructural changes. Further refinement of the analyses is achieved by detailed images generated by these advanced capabilities to ensure complete assessments of tablet integrity.

This friability test is carried out systematically, taking pre-loaded tablets into rotating drum 101, pre-defined test parameters, and real-time images from the scene. The artificial intelligence-powered analysis module 103 gives very clear details about the pattern of breakdown of tablets based on these images. The results are viewed through the user interface 104, along with comprehensive reports generated regarding breakdown analysis and actionable recommendations for the improvement of formulation. The various reports produced enable the formulations of the tablets to be tampered which leads to the increase in product robustness as well as satisfying regulatory standards.

The apparatus for friability testing of pharmaceutical tablets, compact, and self-contained robust corrosion-resistant materials make up its main body and shall withstand even the pharmaceutical environment. There are many components contained in the apparatus:
Main Unit
Rotating Drum 101
Automated Sample Loading Mechanism 106
High-Resolution Imaging System 102
Artificial Intelligence-Powered Analysis Module 103
Variable-Speed Motor 107
Vibration Sensor 109
User Interface 104
Sample Collection System
Self-Cleaning Mechanism 109
Calibration System 110

Embodiments
Rotating Drum 101:
The main and core part where the friability test is conducted is the rotating drum 101. This drum is specially designed with quite a number of innovative features as shown below:
Drum Made Transparent: This transparent polymer drum is extremely strong and is clearly visible by which the tablets are clearly seen during the test.
Available in various sizes: Drum is available in different sizes to accommodate various tablet quantities and sizes, compiled with various pharmacopeia standards.
Internal Baffles: Internal baffles removed and adjusted in order to change the pattern of tumbling for tablets so that customized stress applications achieved.
Quick-Release Mechanism: This product comes with quick-release mechanisms which make it easier to attach and detach the drum from the motor shaft so that cleaning and regular maintenance be performed.

Automated Sample Loading Mechanism106:
The automated sample loading mechanism 106 allows consistent and precise placement of tablet samples in the drum.
Vibrating Feeder: The tablets are fed gently from a hopper through the vibrating feeder into the loading chute.
Optical Counting System: The optical counting system counts the tableted products being loaded accurately.
Articulated Loading Arm: The articulated is loading arm avoids damaging of tablets during loading as it puts them in the drum.

High Resolution Imaging System 102:
The high-resolution imaging system 102 plays an important role in monitoring real time behavior of tablets:
Multiple High-Speed Cameras: The system employs the use of multiple high-speed cameras all placed in different angles around the drum.
LED Lighting Array: It employs customized LED lighting array for peak illumination with a view to sharp image capture.
Image Stabilization: The advanced image stabilization technology allows for clear images even when the drum is rotating.
3D Reconstruction Capability: This system produces 3D reconstructions of the tablets; this avenue permits volumetric damage analysis.

Artificial Intelligence-Powered Analysis Module103:
The AI-powered module analyses the image data in real-time:
Deep Learning Algorithms: Based on a large dataset of tablet image feeds, it uses deep learning algorithms that help identify multiple types of damage.
Real-Time Processing: The on-board, high-performance GPUs process the image data in real time.
Pattern Recognition: The module recognizes even slight changes in the pattern of tablet appearance.
Predictive Analytics: The module forecast potential tablet failures when early signs of wear or stress begin to appear.

Variable-Speed Motor 107:
The variable-speed motor 107 ensures high accuracy in controlling drum speed:
Brushless DC Motor Equipped with efficient brushless DC motor with smooth and consistent rotation.
Digital Speed Control It has microprocessor-controlled speed regulation. This provides the ability to have a precise RPM setting.
Acceleration/Deceleration Control That's progressive speed change, so it won't risk moving your tablet into any destructive sudden movement
.
Vibration Sensor 109:
Vibration sensor 109 monitors the apparatus to detect any abnormal movement:
Piezoelectric Sensor
Sensitive piezoelectric sensor that detects minute vibrations
Multi-axis monitoring the sensor monitors the vibrations in different axes for full coverage.
Real-Time Alert System: It interfaces with the user interface to alert the user right away once it finds abnormal vibrations

User Interface 104:
The user interface 104 allows the user to have a friendly control and real-time information on:
High-resolution Touchscreen Display: This is for ease of work with it and easier data visualization
Custom Test Protocol Creation: Custom protocols created and saved for different tablet formulations.
Real-Time Data Visualization: It offers a live feed from cameras plus real-time results from the analysis.
Report Production: Generates detailed test reports with break down analysis.
-a vibration sensor 108 is attached in the apparatus for detecting any abnormal movements in the apparatus during testing, working and alert the control system.

Sample Collection System:
The sample collection system automates the handling of tablets after a post-test on the table:
Soft Collection Mechanism: The soft cushioned collection tray reduces stress exerted on tested samples additionally.
Weighting: The system includes a high-precision balance, which automatically weighs the samples collected.
Sorting: Separation of intact tablets from fragments for further analysis possible

Self-Cleaning Mechanism109:
The self-cleaning mechanism 109 keeps the apparatus clean and free from contamination:
High-Pressure Air Jets: High-pressure air jets strategically positioned blow the drum and piping system free of dust and fine debris.
UV Sterilization: UV lamps sterilize the drum and other system components between tests.
Automated Washing System: An automated washing system initiated to provide more thorough cleaning.

Calibration System 110:
The Calibration System 110 helps protect the integrity of all:
Automated Calibration Routines: Routine routines check and calibrate multiple system components.
Reference Standards: Houses certified reference materials for the calibration of weight and imaging systems.
Calibration Logging: All calibration activities automatically logged to ensure regulatory compliance.

Test Setup:
User inputs test parameters from the touchscreen user interface.
Users create new protocols or select existing ones.

Automated sample loading mechanism 106:
Automated sample loading mechanism counts tablets precisely and loads into the drum.
Vibrating feeder allows for consistent flow of tablets.
Optical counting system ensures that exact number of tablets is loaded.
The articulated loading arm puts the tablets into the drum in a delicate manner, which minimizes pre-test damage.

Initiation of Test:
The user runs the test using the interface.
The variable speed motor provides a gradate acceleration of the drum to a specified speed.
It activates the high-resolution imaging system to start taking pictures and video recording.

Real-Time Monitoring and Analysis:
High-speed cameras are continuously taking images from different angles.
The LED lighting array is designed to provide maximum illumination, including optical conveyors for crisp image capture.
The AI-based analysis module identifies and quantifies damage in the images of tablets with real-time analysis of live data from camera feed.
The result of analysis is shown on the user interface.
The vibration sensor continuously monitors for abnormal movement.
Test Over
The motor gradually breaks the drum to complete its stop.
When the drum stops completely, the sample collection system is activated to collect the tablets that have undergone the test.
The mechanism for smooth collection ensures no further damage develops during collecting.

Post-Test Evaluation:
The high precision balance carries out automatic weighing for all samples from the collection.
Sorting Ability: There is an option to sort tablets that are whole from broken fragments in case they are fragmented.
AI does comprehensive evaluation of all testing results.
The user interface performs a detailed report with graphical format with information such as weight loss, break up patterns, and how well the actual results of the analysis of the image matches up.
Cleaning and Preparation for Next Test
Self-cleaning cycle triggered to blow off dust and particles from surfaces with strong blasts of air jets.
Starting the automated washing process allows for additional cleaning.
The UV lamps sanitize the drum and other parts.
Calibration and Maintenance:
The calibration system runs automated programs at scheduled times to carry out a check-up and calibration of all elements of the system.
The activities of the calibration are recorded in respect of regulatory compliance.

Additional embodiments
Drum Material Composition:
The drum is molded from high-grade, impact-resistant polycarbonate. Such a material provides optimum visibility while withstanding mechanical stress from repeated testing. It is also resistant to common pharmaceutical cleaning agents.

Baffle Design:
There are unique internal baffles of a curved profile, whose design promotes a more uniform action of tumbling of tablets. The baffles is easily adjusted or removed to modify the stress pattern applied to the tablets.

Mechanism of Optical Counting System:
The optical counting system uses high-speed image processing with infrared sensors. As pills are entering the loading chute, they break the infrared beam and are therefore making it trigger the image capture, which is then made to run through advanced algorithms in real time for accurate counting of the pills passing in succession.

Camera Details:
They shoot up to a frame rate of 1000 frames per second in a resolution of 4K. This makes it support high frame and resolution rates, and the outcome is to allow detailed analysis at the moment that really occurs when tablet damage takes place.

3D Reconstruction Process:
It has photogrammetric capability for 3D reconstruction. This system take various 2D images of the same object from different angles and create high-resolution 3D models of each tablet, so volumetric analysis of damage is possible, revealing both surface abrasion and internal structural changes.

AI Training Dataset:
The algorithms of the deep learning of the AI module were trained on more than a million images of tablets in a huge dataset with several variations, shapes, and damage types. Through this intensive training, the system was able to make correct identifications and classifications among the various modes of tablet breakdown.

GPU Configurations:
The NVIDIA Tesla V100 units are used to give the system real-time processing powered by high-performance GPUs; each of these units contains 5120 CUDA cores and 640 Tensor cores. This processing power allows for a stream of multiple high-resolution images to be analyzed in real time without lag.

Motor Control Mechanism:
Precise rotation speeds are obtained with the help of a PID control loop, controlling the speed of rotation of the motor. This constantly monitors the actual rotation speed and, in turn, makes micro-adjustments to keep the RPM at specified levels, thus keeping conditions constant during tests.

In Sensor Sensitivity:
Its piezoelectric vibration sensor measure vibrations as low as 0.1g. This allows it to spot potential problems, like bearing wear or drum imbalance, well in advance of becoming significant enough to affect test results.

Touch Screen Display Functions:
The multi-touch capacitive touch screen, measuring 15-inch, resolves at 2560 x 1440 pixels. The panel coating is an anti-glare substance that resists glare both indoors and outdoors and also features resistance to common laboratory chemicals.

Data Visualization Tools:
Real-time data visualization is through interactive charts and graphs that update in real-time. It zoom to specific times, overlay multiple data sets, and export raw data for further analysis.
Sample Collection Mechanism
The collection mechanism is soft and pneumatic-controlled conveyor belt system. At the point of exit from the drum, tablets are smoothly conveyed over to a collection tray without a chance of re-damage during collection.
Our Weighing System's Precision
The high-precision balance is incorporated with a precision of ±0.1 mg. It makes use of electromagnetic force restoration technology for fast and accurate measurement even in small weight changes.

Mechanism of Sorting System:
This sorting capability relies on optical recognition and soft blast air. Beneath a high-speed camera, the size and shape of tablets and fragments are analyzed in real time. In response, based upon the analysis, the intact tablets and fragments are guided into separate collection bins by way of precisely timed air jets.

Air Jet Configuration:
In the self-cleaning mechanism 109, the spiral high-pressure air jets are placed inside the drum. Inside placement ensures all surfaces inside the drum get cleansed. Air pressure is finely adjusted so that particles effectively expelled without damaging the material of the drum.

Vibration Sensor:
a vibration sensor is attached in the apparatus for detecting any abnormal movements in the apparatus during testing, working and alert the control system.

UV Sterilization Specifications:
Sterilizing UV lamps used emit light at a 254 nm wavelength in the UV-C spectrum, which is very effective in inactivating microorganisms. It is intended to deliver a UV dose of 40 mJ/cm² over all surfaces for full sterilization.

Washing System Specifications:
It uses a solution of water and mild, non-residue-building detergent designed specifically for pharmaceutical equipment with multiple spray nozzles for thorough coverage and warm air drying so that all parts are dry at the time of the following test.

Calibration Standards:
The calibration of the certified reference materials includes NIST-traceable weight standards for balance calibration as well as optical calibration targets for the imaging system. These standards have been put away within a temperature and humidity-controlled compartment within the apparatus to ensure integrity.

Data Logging and Compliance:
All the tests, cleaning cycles, and calibrations are recorded in a secure database with tamper-evident features. The logging system meets compliance as per 21 CFR Part 11 for nonrepudiation and data integrity with the advantage of traceability for regulatory requirements compliance.

Environmental Control:
Environmental control is installed within the testing chamber by eliminating the fluctuation of temperature and humidity to keep it steady and stable during tests. Especially useful for moisture-sensitive formulations, such environmental controls ensure that the effects of environmental conditions do not be critical to obtaining results.

Adaptive Testing Parameters:
The device comes with an adaptive testing system that adapts test parameters based on observed tablet breakage. For example, if the AI module detects potential deviations earlier than expected when breaking the tablets, the drum then be adapted at runtime to alter rotation speed or testing time to avoid total breakage of the tablets, thus providing finer data points regarding tablet friability thresholds.

Multi-Batch Comparison:
This system allows running of several batches of the same formulation or different formulations simultaneously. It provides AI module-based comparative analyses that offer differences in friability characteristics among batches or between formulations. It is especially useful during formulation optimization and quality control operations.

Acoustic Analysis:
Besides the optical and vibration sensors, the equipment is also equipped with a high sensitivity microphone array that captures the sounds happening during the test. The AI module analyzes those acoustic signatures as sometimes, such changes in the integrity of the tablets are not always be visible initially, as in internal crack formation.

Thermal Imaging:
A thermal imaging camera is part of the system to monitor the temperature changes in the test, which might be useful for estimating the influence of friction and impacts on tablet surface temperature; these effects are particularly relevant for temperature-sensitive formulations.

Monitoring Electrostatic Charges:
An electrostatic charge sensor is included in order to measure the electrostatic build-up developed in the course of the test. This is particularly important for those formulations that are sensitive to electrostatic charges. This influence powder adhesion and have an indirect effect on results obtained for friability.

AR Interface:
It is equipped with an augmented reality ability to overlay real-time data analysis onto a live view of the rotating drum. In this way, users wearing AR-enabled glasses immediately see visualizations on their tablets of emerging hotspots and breakdown patterns as testing unfolds.
Machine Learning-Based Predictive Maintenance
It utilizes machine learning algorithms to scrutinize data from different types of sensors. Predictive maintenance predicts potential equipment problems before they occur and schedule maintenance to avoid unexpected stoppages.

Formulation Recommendation Engine:
It comes with an AI module with a formulation recommendation engine since it assimilates data from various tests. This means that the engine is able to suggest possible tablet formulations with acceptable friability characteristics for improvement. This reduces the process in the development of the formulation.

Regulatory Compliance Assistant:
The integrated regulatory compliance assistant ensures that all tests are conducted in accordance with the various pharmacopeia standards set. Real-time support for test parameters is provided, and the user receives an alert in case any parameter of the test fails to comply with regulatory requirements.

Remote monitoring and control:
It has a secure remote access feature. This allows authorized personnel to monitor tests and see test results, including controlling the equipment from remote locations. This is especially useful for multi-site pharmaceutical companies and in order to enable expert support.

Automatic Particle Size Analysis:
For those tablets that break in testing, an automated particle size analysis system sorts and measures the pieces produced. This gives a high level of detail on the mode of tablet breakage, which is important for further improvement of formulation and understanding.

Environmental Simulation Chamber:
An advanced environmental simulation chamber makes it possible to test friability under a range of temperature and relative humidity conditions. This facility is essential in establishing the impact of environmental conditions on the friability of tablets, particularly in products intended for market launch in different global markets.

Continuous Flow Testing Mode:
There is continuous flow mode within the equipment, which is appropriate for high-volume testing. In this mode, tablets are fed continuously into and removed from the drum, thereby allowing extended testing periods or the processing of large sample sizes without requiring human intervention.

Multi-Layer Tablet Analysis:
For multi-layer or coated tablets, the system contains advanced imaging and analytical ability, allowing individual assessment of layer friability. This capability addresses questions regarding how contributory factors within complex tablet formulations contribute towards overall friability.

Nano-Surface Imaging:
Atomic force microscopy principles create highly detailed maps of the surface of tablets before and after testing with an integrated nano-surface imaging system. The high-resolution imaging captures changes in the microscopic structure of the tablet surface that is not be visible through conventional imaging.

Artificial Neural Network for Data Interpretation:
Advanced data interpretation employs an artificial neural network. These networks identify invisible and discerned patterns and trends within the friability data and uncover new information on the factors affecting the durability of tablets.

Blockchain Technology for Data Security:
All the test data, calibration records, and system logs are encrypted with the help of blockchain technology to ensure maximum data integrity and traceability by storing them safely and tamper-proof.

Voice-Controlled System:
The user interface include a voice control system to allow operators to provide commands and retrieve test status without having to glance at the screen. It is ideal for when there are operators performing other tasks, or working in a sterile environment.

Automatic Tablet Recognition:
The automatic system for the recognition of tablets in table recognition employs computer vision and machine learning in scanning, recognizing, and classifying the types of tablets through their shape, size, color, and markings. With this, the correct test protocol to be applied automatically adheres to the specific type of each batch.

Energy Efficiency Optimization:
It is also fitted with an energy efficiency optimization system, making the power consumption of the device adaptive to the workload it faces at any given time. It saves energy expense as well as cuts down its carbon footprint on friability testing.

Usable stress patterns:
Apart from the standard rotation movement, the drum programmed to create customized stress patterns that include rotations with speed variation, direction changes, and even slight tilting, which are more comprehensive than stress tests that is mirror a range of conditions of real stresses found in the world.

Dust Analysis System:
Highly sensitive dust analysis system captures and analyzes any dust or small particles generated during the friability test. That provides more information on erosion patterns and quite helpful in assessing the performance of tablet coatings.

Automated cleaning validation:
This mechanism also incorporates an automated cleaning validation system. For every cleaning cycle, the system verifies whether the surfaces have been adequately cleaned and without cross-contamination between tests using UV fluorescence with image analysis.

Virtual Reality Training Module:
Together with the apparatus, there comes a comprehensive virtual reality training module. This allows for training on the equipment with its interpretation of the results in a simulation environment, saving time and reducing the risk of error as when using the apparatus.

Tablet Trajectory Tracking:
The system tracks the trajectory of tablets in the drum using high-speed imaging and advanced algorithms for motion tracking. This demonstrates what happens with tablets of different shapes and sizes during the test, hence an indication of the formulation and design of tablets.

This is the first apparatus known in a pressurized, friction-controlled tabletop environment. Its basis on different advanced features and functionalities makes it predominant over every known apparatus. Providing unprecedented amounts of data and analysis, it gives pharmaceutical companies more powerful insights into how tablets behave; it is more effective in optimization of formulation, and ultimately leads to higher-quality, more reliable drug products. It is embedded with technologies like AI, ML, block chain, and advanced imaging systems place this apparatus at pharmaceutical quality control and research tools.

Applications:
Formulation Optimization:
This provides extraordinarily detailed information from which the formulators optimize compositions to unprecedented precision. AI-driven formulation recommendation engines suggest excipient ratios or manufacturing processes adjustments to improve tablet robustness, allowing tremendous reductions in the iterations of formulation cycles that accelerate timelines to drug development.

Quality Control Enhancement:
Through continuous flow testing mode, the apparatus makes high-volume, real-time quality control at the production site possible. Real-time feedback about the friability of tablets empowers manufacturers to alter their parameters quickly in production to reduce waste and maintain product quality.

Regulatory Compliance:
The regulatory compliance assistant ensures that all tests are run in accordance with current standards by pharmacopeia. Furthermore, the detailed data logging and blockchain-based security give an immutable audit trail that simplifies any regulatory inspections and submissions.

Research and Development:
The ability of the apparatus to simulate different environmental conditions and apply customized stress patterns offers the R&D departments greater comprehensive product stability studies. This helps develop products suited to diverse global markets with different climatic conditions.

Process Analytical Technology Integration:
The equipment supports FDA's Process Analytical Technology initiative. Real-time monitoring and analysis ensure quality at the point of manufacturing, hence aligning with the goals of a more proactive, data-driven approach to pharmaceutical production.

Cross-Functional Collaboration:
The remote monitoring and control feature facilitates collaboration across team locations. Formulation scientists, quality control specialists, and production managers simultaneously access real-time data to facilitate quicker decision-making and problem-solving.

Predictive Maintenance in Manufacturing:
The predictive maintenance system developed with machine learning further extended to other machinery in the production line. The possibilities of faults before their occurrence help in reducing unpredictable downtime and hence ensuring an overall efficient operational cycle.

Advanced Coating Analysis:
Nano-surface imaging and dust analysis system provide essential details concerning coating integrity and performance. It is particularly valuable for developing and optimizing controlled-release formulations or enteric coatings.

Comparative Product Analysis:
At this site, the equipment allows companies to compare multi-batch their products with competitors or compare different manufacturing site's output. This help in strategic input into optimum positioning of the product and optimum manufacturing optimization.

Technology Transfer:
The equipment produces a range of data that enable better transfer technology between a development site and a production site. The detailed profiles of friability help maintain consistency in tablets manufactured in the various facilities as regards quality characteristics.

Patient-Centric Formulation:
The equipment allows for developing a formulation that is patient-focused, as more precise data regarding the behavior of tablets are provided. For instance, it is used in designing tablets that are hardy enough for different dispensing systems, yet those which easily be broken by the patients in case dosages are to be adjusted.

Supports Continuous Manufacturing:
Since the pharmaceutical industry is moving towards the achievement of continuous manufacturing, the equipment should be able to provide minute, real-time friability information. So it easily fit within a continuous production line and not necessitates batch testing for consistent product quality.

Artificial Intelligence in Pharmaceutical Development
This integration of advanced AI and machine learning algorithms into the apparatus becomes a prototype that scaled up to larger pharmaceutical development. This comes across on how AI put into better use in improving decision-making processes, revealing relationships not immediately obvious in complex formulation data.

Greener Pharmacy Initiatives
It supports the growing industry efforts toward the greener production of pharmaceuticals. Since it saves energy and waste through a precise formulation, it supports the principles of a green pharmacy.

Personalized Medicine:
With this increase in the field of personalized medicine, where small batches of customized formulation are under research, the ability to evaluate and optimize such customized formulation promptly becomes relevant. The versatility and capability to analyze small components aid in producing and monitoring quality of personally designed drug products.

Virtual Twin for Manufacturing:
From the information produced by the equipment, several digital twins maintained with information of the entire manufacturing process. This is utilized in optimization of production parameters, forecasting outcomes, and training personnel without a disruption to real manufacturing.

Augmented Workforce:
Features, for example, augmented reality interface and voice-activated control, are excellent examples of developing an augmented workforce in pharmaceutical manufacturing. These technologies ensure that optimum efficiency is achieved from the operators involved in the quality control process while minimizing human error.

Risk-Based Quality Management:
The device fosters a risk-based quality management approach because it has comprehensive data and predictive capabilities. Therefore, it allows companies to point out the early occurrences of possible issues and go into the detailed friability profile.

Advancement of Regulatory Science:
The new analytical capabilities of the equipment, including acoustic analysis and electrostatic charge monitoring, contribute to the field of regulatory science. The resultant information used in any potential future regulatory requirements to satisfy quality and stability for the tablets.

Global Supply Chain Resilience:
This also helps to develop products that face and withstand the rigors of global supply chains by enabling varied environmental conditions. This is particularly important as the pharmaceutical supply chain becomes increasingly complex and reaches out into more remote parts of the world.
, Claims:1. A friability testing apparatus for pharmaceutical tablets 100 comprising:
a) a rotating drum 101 for holding tablet samples;
b) a high-resolution imaging system 102 configured to capture real-time images of tablets during testing;
c) an artificial intelligence-powered analysis module 103 configured to process image data and identify tablet breakdown patterns;
d) a user interface 104 for displaying test progress and results; and
e) a control system 105 for managing test parameters and apparatus functions.

2. The apparatus as claimed in claim 1, further comprising an automated sample loading mechanism 106 configured to precisely count and load tablets into the rotating drum.

3. The apparatus as claimed in claim 1, further comprising a variable-speed motor 107 for controlling the rotation of the drum, wherein the motor speed is adjustable based on test parameters or real-time analysis of tablet behavior.

4. The apparatus as claimed in claim 1, wherein the artificial intelligence-powered analysis module 103 uses deep learning algorithms trained on a dataset of tablet images to identify various types of tablet damage.

5. The apparatus as claimed in claim 1, further comprising a vibration sensor 108 configured to detect abnormal movements during testing and alert the control system.

6. The apparatus as claimed in claim 1, further comprising a self-cleaning mechanism 109 that includes high-pressure air jets and UV sterilization capabilities.

7. The apparatus as claimed in claim 1, further comprising a calibration system 110 configured to maintain accuracy of all components through automated calibration routines.

8. The apparatus as claimed in claim 1, further comprising an acoustic analysis system 111 configured to capture and analyze sounds produced during testing to detect subtle changes in tablet integrity.

9. The apparatus as claimed in claim 1, wherein the user interface 104 includes an augmented reality feature used to overlay real-time analysis data onto a live view of the rotating drum.

10. A method of testing the friability of pharmaceutical tablets in the friability testing apparatus as claimed in claim 1 comprising:
a) loading a sample of tablets into a rotating drum of a friability testing apparatus;
b) initiating a friability test with predefined parameters;
c) capturing real-time images of the tablets during the test using a high-resolution imaging system;
d) analyzing the captured images using an artificial intelligence-powered module to identify and quantify tablet breakdown patterns;
e) displaying real-time test progress and results on a user interface; and
f) generating a comprehensive report of the friability test results including detailed breakdown analysis and recommendations for formulation improvements.

Documents

NameDate
202411088776-COMPLETE SPECIFICATION [16-11-2024(online)].pdf16/11/2024
202411088776-DECLARATION OF INVENTORSHIP (FORM 5) [16-11-2024(online)].pdf16/11/2024
202411088776-DRAWINGS [16-11-2024(online)].pdf16/11/2024
202411088776-EDUCATIONAL INSTITUTION(S) [16-11-2024(online)].pdf16/11/2024
202411088776-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [16-11-2024(online)].pdf16/11/2024
202411088776-FIGURE OF ABSTRACT [16-11-2024(online)].pdf16/11/2024
202411088776-FORM 1 [16-11-2024(online)].pdf16/11/2024
202411088776-FORM FOR SMALL ENTITY(FORM-28) [16-11-2024(online)].pdf16/11/2024
202411088776-FORM-9 [16-11-2024(online)].pdf16/11/2024
202411088776-POWER OF AUTHORITY [16-11-2024(online)].pdf16/11/2024
202411088776-PROOF OF RIGHT [16-11-2024(online)].pdf16/11/2024
202411088776-REQUEST FOR EARLY PUBLICATION(FORM-9) [16-11-2024(online)].pdf16/11/2024

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