INSTRUMENT FOR TOPICAL PHARMACEUTICAL PRODUCTS

Abstract

The present invention discloses a spreadability check instrument (100) designed for precise, automated evaluation of topical pharmaceutical products. The instrument comprises a temperature-controlled base plate (101) with a sample well (102) and a movable upper plate (103) connected to a force-controlled actuator (104). Real-time imaging of the spreading area is achieved through a high-resolution camera (105), while force and displacement sensors (106, 107) ensure accurate monitoring. A microprocessor-based control system (109) automates testing, data acquisition, and analysis, with a user interface (110) enabling test parameter input and visualization of results. Additional features include a Peltier element (111) for temperature control, an adaptive force system (113), multi-wavelength optical analysis (114), rheological profiling (115), and a 3D mapping system. The instrument ensures reproducible spreadability measurements, offering environmental simulation and AI-based test optimization. This invention facilitates precise quality control and formulation studies for pharmaceutical applications.

Specification

Description:The spreadability check instrument 100 on topical pharmaceutical products provides an accurate, automated solution for measuring spreadability formulations. It features a temperature-controlled base plate 101 with a sample well 102 to hold test samples. The movable upper plate 103, controlled by a force actuator 104, applies precise pressure on the sample when testing. A high-resolution camera 105 captures real-time images of the spread of the sample, and force sensor 106 and displacement sensors 107 monitor the applied force and motion of the plate. All of this data is then processed through a microprocessor-based control system 109, which automates test procedures, acquires data, and calculates results. Results are then visualized for the users who input parameters, thus allowing them to review test outcomes.

The Peltier heating and cooling element 111 is utilized within the base plate to maintain temperature control. Environmental protection enclosure equipped with control features mounts the instrument to retain perfect conditions for testing. Adaptive force-control ensures spreading process constancy through real-time adjustments of pressure. Also, part of the configuration is a multiwavelength optical analysis system 114 to study properties of a formulation during spreading, along with a rheological profiling module 115 that characterize viscoelastic behavior. Also, a 3D surface mapping system creates detailed maps of spread samples for further texture and surface analysis.

Another advanced automation feature ensures the loading of an automated sample into a system where placement and deposition are ensured without error. An environmental simulation chamber allows tests under different conditions to forecast real-world performance. Additionally, an optimization system based on artificial intelligence offers ideal test parameters from past data and analysis. All these put together provide very high accuracy in, as well as the reproducibility of, spreadability assessments that is important in pharmaceutical quality control.

It has a 200 mm diameter base plate and the sample well is 30 mm in diameter by 2 mm in depth. Suitable for topical formulations, the instrument allows for real-time monitoring and features an optical-grade transparent acrylic movable upper plate. For example, the force-controlled actuator applies forces between 5 and 500 grams to accuracy of ±0.1 gram, a force sensor has an accuracy up to ±0.05 grams, and a displacement sensor determined to 0.01 mm. In addition, a controlled condition throughout the testing base plate of the shaker maintains a temperature range between 20°C and 40°C with accuracy of ±0.1°C.

During its operation, the microprocessor-based system performs such important spreadability parameters as the spreading coefficient, yield value, and consistency. The device additionally has a capacitive touchscreen 10-inch display to simplify operating control and data visualization.

The method of spreadability test is as follows: it starts with the input of test parameters by a user from the interface. The control system initiates the test sequence after loading the sample into the well. The actuator, force-controlled applies the required force while the camera captures images at real-time. All parameters, such as force, displacement, temperature, and spread area, are continuously monitored and recorded. The processed data is then used to compute spreadability parameters along with creating a comprehensive report including numerical data, graphs, and statistical analysis. This advanced instrumentation thus allows the pharmaceutical developer to get informative insights into the spread behavior of topical formulations developed in terms of product development and quality assurance.

Temperature-controlled base plate and Sample Well (101, 102)
The apparatus boasts the generally circular stainless-steel Temperature-controlled base plate 101 with a diameter of 200 mm. The center of this base has a recessed sample well 102 measuring 30 mm in diameter by 2 mm deep. The well thus provides accurate sample location and volume when conducting any test. The base plate is equipped with a Peltier heating and cooling element 111, with a temperature range from about 20° C up to 40° C, and is provided with an accuracy of ±0.1° C. Temperature control feature enables testing spreadability characteristics under conditions physiologically relevant.

Embodiments
Movable Upper Plate 103 and Force-controlled actuator 104
Above the base plate a movable upper plate (103) made of 50 mm diameter transparent, optical grade acrylic is constructed. This upper plate is mounted on a Force-controlled actuator (104) that is capable of applying controlled forces between 5 to 500 grams with accuracy of ±0.1 g. The actuator applies these forces to gain precise vertical movement through a stepper motor and lead screw mechanism that allows for the controlled compression of the sample between the plates.

High-resolution camera (105)
A high-resolution digital camera (105) is mounted above the movable upper plate (103). The camera captures live images of the spreading sample through the transparent upper plate. The camera is connected with a microprocessor system which, with advanced image processing algorithms, calculates the spread area to an exceptionally high degree of precision.

Force Sensor and Displacement Sensor (106, 107)
A load cell force sensor (106) that is integrated into the movable upper plate (103) assembly has a resolution of ±0.05 grams to measure the applied force, while a linear variable differential transformer (LVDT) displacement sensor 107, monitors the vertical motion of the upper plate with a resolution of 0.01 mm. These sensors record the essential data for the force-displacement relationship created during the spreading process.

Temperature Sensors (108)
Multiple temperature sensors (108) such as precision thermistors (108A) are located in important locations around the instrument to measure the temperature at key points:
- Are attached to baseplate to provide monitoring of sample temperature
- Are positioned adjacent to the sample well to sense ambient temperature
- Are placed in the instrument case to monitor system wide temperature
These sensors are employed for independent thermal control of the system and allow temperature-dependent testing of spreadability characteristics.

Microprocessor-based control system (109)
The instrument is a powerful control system based on a microprocessor that orders all aspects of the test procedure. This system controls:
Movement and applied force on actuators.
Acquisition and processing of all data of sensors.
Image analyses coming from the camera to calculate spread area.
Executing the test protocols with a real-time calculation.
The management of data storage and communication with outer systems.
The firmware implemented in the microprocessor implements control algorithms to perform accurate tests with the analysis of obtained data; this is realized with PID (proportional-integral-derivative) and adaptive force control in order to maintain the spreading forces constant during the test.

User Interface (110) and Data Management
The 10-inch capacitive touchscreen display is the central user interface 110. The intuitive graphical interface allows operators to:
- Input test parameters and sample information
-Choose pre-set test protocols or create a new ad hoc protocol
-Live online viewing of the test execution with real-time data view
-Interactive graph and report result and analysis
-System has 256 GB of solid-state storage for the test data and result. In addition, there are USB and Ethernet ports to export the data or integrate into any LIMS.

Enclosure (112) with Environmental Control
The whole apparatus is placed inside a sleek, temperature-controlled enclosure (112) in which a controlled environment is provided for testing. The enclosure 112 comprises of
Translucent acrylic covers for visibility
HEPA filtration is for a clean test.
LED lighting is to allow good illumination of samples during imaging.

Test Procedure and Operation
The spreadability check instrument operates on the following steps:
1. The test parameters are fed into the apparatus by the operator through the touchscreen of user interface (110). These include sample type, test duration, applied force, and the set temperatures.
2. Temperature-controlled base plate (101) to the set temperature is carried out using a Peltier heating and cooling element (111).
3. A calibrated pipette and dispensing system loads a fixed amount of the topical product sample in the sample well (102).
4. The operator initiates a test; the microprocessor-based control system (109) takes over control of experiments.
5. The movable upper plate (103) travels downward at a controlled speed until it makes contact with the sample surface, monitored by the force sensor (106).
6. The force-controlled actuator (104) applies a given amount of demanded force, and the high-resolution camera (105) begins to image the spreading sample.
7. As the testing time, the system continuously monitors and writes down:
- Force applied from the force sensor (106)
- Displacement of the plate by the displacement sensor (107) includes LVDT sensor.
- Sample and ambient temperatures through the thermistors in temperature sensors (108)
- Spread area inferred from images taken by the high-resolution camera (105)
8. This information is processed in real time by the microprocessor-based control system (109) to generate all the parameters that describe spreadability, including the spreading coefficient, which is defined as the rate of increase of the area with time.
- Yield value (minimum force applied to trigger spreading)
- Consistency (proportionality of force applied to spread area)
9. On completion of the test, the movable upper plate (103) retracts, and the system provides a detailed report with numeric values, graphs, and statistical analysis.
10. Test results are viewed on the touchscreen in user interface (110) and transmitted to external systems for input into other systems, records, etc.

Further Releasable Implementations
1. Adaptive Force Control (113): New algorithm that dynamically adjusts the exerted force applied to keep the pressure constant as a sample spread and maintain conditions uniform along the experiment.

2. Multi-Wavelength Optical Analysis system (114) This module combines multi-spectral LEDs and filters with the imaging system, enabling analysis on the opacity of samples, color changes, and even phase separations that occur due to spreading.

3. Rheological Profiling Module (115): Optional attachment with a small-amplitude oscillatory shear mechanism whereby one measure the viscoelastic properties concurrently with spreadability testing.

4. 3D Surface mapping system: Structured light projection combined with stereo vision techniques to make a three-dimensional mapping of the spread sample, which provides information about texture and uniformity.

5. Automated Sample Loading System (116): Features an accurate dispensing mechanism that correctly drops the volume of sample into the well with minimal variability in the preparation of samples.
6. Texture Analysis Integration feature: There is an inclusion of a texture analyzer probe that perform penetration and compression tests on the spread sample directly after the spreadability test to provide more textural information.

7. Environmental Simulation Chamber: A enclosure system, which simulate a variety of environment conditions, such as high humidity or air flow, to determine their effects on spreadability properties.

8. Artificial Intelligence-Driven Test Optimization system: Application of algorithms to critically assess historical test data for the purpose of indicating optimal test parameters for new formulations in order to streamline the process of development.

Method of performing the Invention
The spreadability check tool is an optimized one that carefully designs to achieve maximum sensitivity and reproducibility, totally maximizing performance of the system. The spreadability test conducted under the following procedure.

1. System Preparation:
Turn on the equipment. In case of hygroscopes and psychrometers, wait for 30 minutes before using the instrument with its sensor stabilized to warm up.
- Indicates calibration material from standardized test.

2. Protocol Setup Testing
- If available, access the user interface (110) by logging in, then choose existing test protocols or design a new protocol
- Input information on sample, product, batch number, and formulation as necessary
- Choose test parameters:
- Sample temperature: usually 32°C in order to simulate the temperature of the skin
- Force applied (start with 50 grams and as needed to product viscosity).
- Duration (test usually 40-120 seconds but dependent on the product).
- Image capture rate (recommend every 0.5 seconds for High Resolution data).
3. Sample Preparation
- The sample is homogeneous. It is stirred gently, if necessary.
- Pipette 1.0 mL of the product into the sample well using the automated sample loading system (116).
Wait 5 minutes for equilibration of the sample to the set temperature.

4. Test Running
Enter the test sequence from the user interface.
The system automatically lowers the movable upper plate (103) and begins spreading.
- Observe the time-dependent display of the results to validate successful testing.

5. Analysis of Data:
After running the test, evaluate the automatically produced spreadability curve.
Calculate the following parameters for maximum spreadability:
- Spread area at time t=0 to 40
- Spread area at time t=40 to120 seconds
- Spreading coefficient (slope of the area vs. time curve)
- Yield value (force at which spreading initiates)

6. Detailed Analysis:
- Carry out the multi-wavelength optical analysis system (114) to assess color homogeneity at spreading.
- If relevant, carry out the texture analysis integration feature not long after the spreading test has been conducted.
For intricate formulation, the rheological profiling module (115) is employed to extract viscoelastic data.

7. Environmental Testing
Products that are sensitive to environment conditions are tested for spreadability under various levels of humidity and air-flow using the environmental simulation chamber.

8. Data Management
The test report that is consolidated is then exported into LIMS for record keeping and further analysis.
Apply the AI-driven test optimization system to optimize test parameters for future runs of similar formulations.

9. System Maintenance
Clean the temperature-controlled base plate (101) and movable upper plate (103) thoroughly with an appropriate solvent after every test. force sensor (106) and displacement sensor (107) weekly. Check performance by certified reference materials monthly.
, Claims:1. A spreadability check instrument 100 for topical pharmaceutical products, comprising:
a temperature-controlled base plate (101) with a sample well (102);
a movable upper plate (103) connected to a force-controlled actuator (104);
a high-resolution camera (105) for real-time imaging of the spread sample area;
a force sensor (106) for measuring applied force;
a displacement sensor (107) for tracking movement of the upper plate;
temperature sensors (108) for monitoring base plate and ambient temperatures;
a microprocessor-based control system (109) for automating test procedures, data acquisition, and analysis; and
a user interface (110) for input of test parameters and result visualization;
wherein the instrument used to provide automated, precise, and reproducible measurement of spread ability parameters for topical pharmaceutical formulations.

2. The spreadability check instrument as claimed in claim 1, further comprising:
a Peltier heating and cooling element (111) integrated with base plate for precise temperature control;
an enclosure (112) with environmental control features;
an adaptive force control system (113) for maintaining constant pressure during sample spreading;
a multi-wavelength optical analysis system (114) for assessing sample characteristics during spreading;
a rheological profiling module (115) for measuring viscoelastic properties;
a 3D surface mapping system for creating three-dimensional maps of spread samples;
an automated sample loading system (116) for precise sample deposition;
a texture analysis integration feature for performing additional textural tests;
an environmental simulation chamber for testing under various environmental conditions; and
an artificial intelligence-driven test optimization system for suggesting optimal test parameters.

3. The spreadability check instrument as claimed in claim 1, wherein the base plate (101) is circular with a diameter of 200 mm and the sample well with a diameter of 30 mm and a depth of 2 mm.

4. The spreadability check instrument as claimed in claim 1, wherein the movable upper plate is made of transparent, optical-grade acrylic with a diameter of 50 mm.

5. The spreadability check instrument as claimed in claim 1, wherein the force-controlled actuator is capable of applying forces ranging from 5 to 500 grams with an accuracy of ±0.1 grams.

6. The spreadability check instrument as claimed in claim 1, wherein the force sensor (106) has an accuracy of ±0.05 grams and the displacement sensor (107) have a resolution of 0.01 mm.

7. The spreadability check instrument as claimed in claim 1, wherein the temperature-controlled base plate (101) is capable of maintaining temperatures ranging from 20°C to 40°C with an accuracy of ±0.1°C.

8. The spreadability check instrument as claimed in claim 1, wherein the microprocessor-based control system (109) is configured to calculate spreadability parameters including spreading coefficient, yield value, and consistency.

9. The spreadability check instrument of claim 1, wherein the user interface (110) comprises a 10-inch capacitive touchscreen display.

10. A method for measuring spreadability of topical pharmaceutical products using the instrument as claimed in claim 1, comprising the steps of:
a) inputting test parameters through the user interface (110);
b) loading a sample into the sample well (102);
c) initiating an automated test sequence controlled by the microprocessor-based control system (109);
d) applying a specified force to the sample using the force-controlled actuator (104);
e) capturing real-time images of the spreading sample using the high-resolution camera (105);
f) continuously monitoring and recording applied force, plate displacement, temperatures, and spread area;
g) processing collected data to calculate spreadability parameters; and
h) generating a comprehensive report including numerical data, graphs, and statistical analysis.

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