FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
1. TITLE OF INVENTION
AN ULTRASONIC INSTRUMENT INDICATING HOMOGENIZATION END POINT
2. APPLICANT (S)
a)Name: VHB Medi Sciences Limited b) Nationality: Indian
c)Address: 50/AB, Government Industrial Estate, Charkop Naka, Kandivali (W), Mumbai- 400067
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:

Field of Invention
The present invention relates to analyzing the homogeneity and finding the end point of homogenization/ mixing of immiscible liquids, particles in liquid etc.
Background of the Invention
High pressure homogenization (HPH) is a technology widely used in various industries. High pressure homogenization can be viewed as a wet micronization technique capable of achieving micron and sub-micron particle sizes. In the pharmaceutical industry HPH is used in broad range of applications such as cell rupture, dispersions, emulsions and particle size reduction. Many of today's active pharmaceutical ingredients (APIs) exhibit low solubility and permeability. In order to improve their bioavailability, these APls are often milled to small sizes.
HPH is carried out to micronize or reduce the particle size of the liquid pharmaceutical products, to make a dispersion of the active ingredients much more stable for enhanced clinical effectiveness. The bioavailability of active pharmaceutical ingredients in the product prepared for medical dosing is improved with optimized particle micronization and homogeneous distribution. This means improved tolerance of drugs on patients with calibrated and reduced dosage. It is a systematic approach for controlling panicles size of immiscible components.
High pressure homogenization can also be applied to recombined nutritional products with optimized formulation and to sub-micron intravenous emulsions. The homogenization technology is being used efficiently in order to obtain the micronization required by the vaccines pharmaceutical industry. The high pressure homogemzer allows micronizing the oil droplets to obtain a very small particle size distribution (0.5 μm mean size) and stabilizing the emulsion over time.
The present invention is about finding the end point of homogenization.
Prior Art
Homogenization (known in the pharmaceutical industry as micronization) is the process of reducing the particle sizes of pharmaceutical products, under very high pressures, to make them more stable and clinically effective. Analysis of the homogenization treatment is carried out to check if the desired effect of reducing particle size is achieved. Analyzing the samples using Raman spectroscopy is a traditional method to assess homogeneity. Alternatively, the samples are analyzed using Particle size analyzer type Coulter LS130 that uses a laser diffraction and P1DS technology to rapidly determine particle size distribution of materials. Homogenization can also be analyzed using microscopic examination. Confocal laser scanning microscope (CLSM) together with SEM is used to characterize or for homogenization analysis of micro-inhomogeneous clay materials. Digital image based modeling to derive accurate microstructural a model is also applied to the homogenization analysis of composite material.

Patent US 6212485 discloses a method for analyzing micro-inhomogeneous material. According to the method, the behavior of the microinhomogeneous material is analyzed by finding particle data of all particles of atoms and/or molecules of the constituent materials of the micro-inhomogeneous material under given physicochemical conditions by using a molecular simulation method; (b) applylng a statistical thermodynamics procedure to the particle-data for determining volume-averaged material properties, and (c) applying a homogenization analysis for a set of differential equations in which the bulk properties are used for predicting behavior of the structure, and calculating field variables distributed in the microinhomogeneous material and (d) comparing the field variables in each constituent material with a predetermined material standard of the field variables for judging whether or not the predetermined physicochemical conditions are feasible for the constituent materials.
Statement of the invention
The present invention is about analyzing of homogenization process to determine whether the end point of the homogenization process is reached. The instrument is developed for the determination of the homogeneity by using ultrasonic receiver and transmitter placed at various planes and angles. The output is collected in the form of frequency/ amplitude/ wavelength. The data is collected with the set of receivers and transmitters through a Programmable Logic Controller (PLC), The output is then collected in an oscilloscope that converts it into a visual expression of homogenization.
Description of the invention
Homogenization is an important requirement for emulsion, colloidal solution dispersing particles in liquid and mixing of two or more immiscible liquids. High pressure homogenization (HPH) is increasingly being used by the pharmaceutical industry to enhance the solubility, or- bioavailability, of active pharmaceutical ingredients (APIs). The degree of solubility or bioavailability enhancement, as well as properties such as chemical stability and physical characteristics, will be dependent on the homogeneity of the composition.
The present invention is about finding the end point of homogenization. The instrument is developed for analyzing homogeneity of the composition and so the end point of the homogenization process. The instrument developed makes use of the ultrasonic sound waves. Ultrasonic sound waves have frequency above 20 KHz. These sound waves can not be normally heard by human ear. Ultrasonic waves find applications in almost all branches of technology and science; to name few - ultrasonic welding of PVC, cleaning, flowmeter, determination distance, nano particle generation, medical devices, etc. Ultrasonic waves are characterized by wavelength, frequency, amplitude and velocity.
Ultrasonic waves are generated by transducer. They convert electrical energy into mechanical sound energy. Electromechanical transducers are far more versatile and magnetostrictive devices.

When ultrasonic sound waves pass through liquid medium attenuation of sound waves takes place i. e, intensity of sound waves diminishes with distance causing change in amplitude.
A = A° e-αz (Nepers/ meter)
Wherein
A° = Initial unattenuated amplitude
A = Attenuated amplitude α = coefficient of attenuation z = distance travelled to get A
e = exponential = 207182$
α=(0.1151 /v)xvt
Wherein
v = velocity
vt = attenuation = decibels/ time
z =pv
Wherein
z = acoustic impedance
p = density
v = velocity
Sound waves propagate in four forms: longitudinal, shear waves, surface waves and plate waves, out of which longitudinal propagation is followed in liquid. For longitudinal waves, the oscillation occurs in the longitudinal direction. Condensation and rarification happens during transmission of these waves. They are also called as pressure waves. Compression and rarification depends on the nature of material, size of particle, density, etc. of the medium through which the wave passes.

Transverse waves are normally shear waves. They are weak in comparison to longitudinal waves.
In case of the instant instrument, the sound, first, travels through solid material as transverse wave or shear wave. When it enters in liquid medium longitudinal waves propagate in liquid.
The longitudinal waves travelling through liquid medium travel at different speed depending upon the type/ density of the medium.
The instrument developed for analysis of homogenization and for end point determination of homogenization comprises of transmitter, transducer, receiver, processor, display device and storage device. The instrument has ultrasonic receiver and transmitter placed at various planes and angles. The output is collected in the form of frequency or amplitude or wavelength (or a combination of any of these). The data is collected with the set of receivers and transmitters through a Programmable Logic Controller (PLC). The output is then collected in an oscilloscope that converts it into a visual expression of homogenization.
Example 1
To find the end point of homogenization, the instrument developed comprises ultrasonic receiver and transmitter placed at various planes and angles. The output is collected in the form of frequency/ amplitude/ wavelength. The data is collected with the set of receivers and transmitters through a Programmable Logic Controller (PLC). The output is then collected in an oscilloscope that converts it into a visual expression of homogenization.
In case of high pressure homogenizer, the above system is connected to a receiver from where the suction takes place. Fig. 1
Where,
Rx: Receiver
Tx: Transmitter
C: Programmable Logic Controller
O: Oscilloscope
P: Printer
H: Homogenizer

Example 2
In case of suspended high-pressure homogenizer, the sensors are fitted in chord Fig 2
Where,
S: Stirrer
A: Homogenizer with suspended stirrer
B: Cross section of Homogenizer with suspended stirrer
and all the systems are identical to the Fig 1

We claim:
1. The instrument for analyzing homogeneity of the composition or to analyze end point of the homogenization process comprising of sensors, receivers, transducers, transmitters, processor, display device and storage device.
2. The instrument as claimed in claim 1 wherein the receiver is ultrasonic receiver
3. The instrument as claimed in claim 1 wherein the data is collected from transmitter in the form of frequency or amplitude or wavelength or a combination of any of these.
4. The instrument as claimed in claim 1 wherein the data is collected with the set of receivers and transmitters through a Programmable Logic Controller (PLC).
5. The instrument as claimed in claim 1 wherein the output is collected in the oscilloscope that converts it into a visual expression of homogenization.
6. The instrument as claimed in claim 1 wherein for suspended high pressure homogenizer the sensors are fitted in chord.