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EMULSION PREPARATION:

EMULSION PREPARATION 1 B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT Prepared by: Piyush Baraiya Roll no: 04 Guided by : Dr.Jaydeep Patel Dept .Of Pharmaceutics

Outline:

Outline Definition Classification Identification of emulsion Application of emulsion Theory of emulsification Formulation of emulsion Layout Emulsification techniques Specific requirements for production Equipments recommended as per schedule M Flow of material SOP Packaging and labelling BMR BPR Validation Reference B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 2

What is an emulsion :

What is an emulsion An emulsion is a thermodynamically unstable system consisting of at least two immiscible liquid phases one of which is dispersed as globules in the other liquid phase stabilized by a third substance called emulsifying agent. Pharmaceutics –II , R M Mehta,6 th ed,133 3 dispersed phase continuous phase

General types of pharmaceutical emulsions::

General types of pharmaceutical emulsions: 1) Lotions 2) Liniments 3) Creams 4) Ointments 5) Vitamin drops B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 4

Classification of emulsions :

Classification of emulsions 1. Based on dispersed phase - Simple emulsions Oil in Water (O/W) Water in Oil (W/O) - Multiple emulsions Oil-in-water-in-oil (O/W/O) Water-in-oil-in-water (W/O/W) - Micro emulsions (Globule size is less than 120 nm, they appear to be transparent.) 2. Based on size of liquid droplets 0.2 – 50 mm Macro emulsions (Kinetically Stable) 0.01 – 0.2 mm Micro emulsions (Thermodynamically Stable) Theory and Practices Of Industrial Pharmacy,Lachman,3rd ed,510 5

Simple emulsion::

Simple emulsion: B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 6

Multiple emulsion::

Multiple emulsion: Also called emulsion within emulsion They are developed with a view to delay the release of an active ingredient. They have three phases. They may be oil-in-water-in-oil (o/w/o) or of water-in-oil-in-water (w/o/w). B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 7 W/O/W SYSTEM O/W/O SYSTEM = water phase =oil phase

PREPARATION OF MULTIPLE EMULSIONS (TWO STEP METHOD):

PREPARATION OF MULTIPLE EMULSIONS (TWO STEP METHOD) Pak. J. Pharm. Sci., Vo.21, No.1, January 2008, pp.45-50 8

MICROEMULSION:

MICROEMULSION www.perc.com/microemulsion 9 They may be defined as dispersions of insoluble liquids in a second liquid that appears clear and homogenous to the naked eye. They are frequently called solubilised systems because on a macroscopic basis they seem to behave as true solutions. As in micro emulsions the globule size is less than 120 nm , they appear to be transparent. Ex. Etoposide micro emulsion methotraxate micro emulsion

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www.perc.com/microemulsion 10

Identification of emulsion :

Identification of emulsion Dilution test : In this test the emulsion is diluted either with oil or water. If the emulsion is o/w type and it is diluted with water, it will remain stable as water is the dispersion medium" but if it is diluted with oil, the emulsion will break as oil and water are not miscible with each other. Introduction to Ph' Dosage Form,ansel,4th ed,227 11 Add drops of water Add drops of water O/W Emulsion W/O Emulsion Water distribute Uniformly

Identification of emulsion :

Identification of emulsion Conductivity Test: water is good conductor of electricity whereas oil is non-conductor. Therefore, continuous phase of water runs electricity more than continuous phase of oil. Introduction to Ph' Dosage Form,ansel,4th ed,227 12 Bulb glows with O/W Bulb doesn’t glow with W/O Emulsion Emulsion

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Dye Solubility test: Water soluble dye ( methylene blue) will be taken up by the aqueous phase where as oil soluble dye will be taken by oily phase. When microscopically it is observed that water soluble dye is taken up by the continuous phase , it is o/w emulsion. If the dye is not taken up by the continuous phase , test is repeated with oil soluble dye.. Coloring of continuous phase confirms w/o emulsion. This test can fail if ionic emulsions are present. Introduction to Ph' Dosage Form,ansel,4th ed,227 13 Identification of emulsion O/W EMULSION W/O EMULSION water is continuous phase Oil is dispersed phase oil is continuous phase water is dispersed phase

Identification of emulsion :

Identification of emulsion Introduction to Ph' Dosage Form,ansel,4th ed,227 14 Flourescent test: oils give fluorescence under UV light, while water doesn’t. Therefore, O/W emulsion shows spotty pattern while W/O emulsion fluoresces. When a w/o emulsion is exposed to fluorescent light under a microscope the entire field fluorescence. If the fluorescence is spotty, then the emulsion is of o/w-type. However, all oils do not exhibit fluorescence under UV light and thus the method does not have universal application.

Identification of emulsion :

Identification of emulsion CoCl 2 /filter paper test : Filter paper impregnated with CoCl 2 and dried appear to be blue but when dipped in o/w emulsion changes to pink. This test may fail if emulsion unstable or breaks in presence of electrolyte Introduction to Ph' Dosage Form,ansel,4th ed,227 15

APPLICATIONS OF EMULSIONS :

APPLICATIONS OF EMULSIONS B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 16 For prolonged action Taste masking Improved stability Parenteral preparation Enzyme entrapment Increased Oral bioavailability

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Introduction to ph'dosage form,ansel,4th ed,223 17 Theories of Emulsification : 1) Surface Tension Theory: - lowering of interfacial tension. 2) Oriented-Wedge Theory: - mono molecular layers of emulsifying agents are curved around a droplet of the internal phase of the emulsion. 3) Interfacial film theory: - A film of emulsifying agent prevents the contact and coaslescing of the dispersed phase.

Formulation of emulsion::

Formulation of emulsion: aqueous phase:purified water organic phase:arachis oil,cod liver oil,sesame oil,castor oil Emulsifier:acacia,SLS,tween,bentonite Antioxidant:sodium bisulphite,sodium nitrite Preservatives:methyl and propyl paraben Pharmaceutics-II,R M Mehta,6th ed,135 18

Layout for emulsion Preparation Qualitative layout::

Layout for emulsion Preparation Q ualitative layout: www.wintechpharma.com 19 Temp:-25˚C If hygroscopic Temp:- <25˚C If sterile area Temp:-18˚C Humidity:- <40% If hygroscopic Humidity > 40% An area requirement for installation of equipment minimum 30 m 2 .

Quatitative layout::

Quatitative layout: www.wintechpharma.com 20

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B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 21 PRE – MIX OR CRUDE DISPERSION HOMOGENIZE FINE DISPERSE DELIVERY SYSTEM OTHER ADDITIVES (FLAVOURS, COLOURING AGENT) VOLUME ADJUSTMENT pH ADJUSTMENT Disperse phase Continuous phase

Emulsification techniques (Lab. Scale) :

Emulsification techniques (Lab. Scale) Dry gum method Wet gum method Bottle or Forbes bottle method Auxiliary method In situ soap method Pharmaceutics-II,R M Mehta,6th ed,142 22

Preparation of emulsions- large scale:

Preparation of emulsions- large scale Mechanical equipment for emulsification (Agitation) Mechanical stirrers -Propeller type mixers -Turbine mixers Homogenizers Colloid mills Ultrasonifiers Theory and Practices of Industrial Pharmacy,Lachman,3rd ed,510 23

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schedule M/part-IC 24 Building and equipment Purified water Manufacturing Supplementary guideline for manufacture of liquid preparation :

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schedule M/ part-IC 25 L ayout and design of the manufacturing area:- Manufacturing area:- Drainage:- Production area:- Equipment design:- Closures and droppers:- Furniture:- 1) Building and Equipments:-

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schedule M/ part-IC 26 Chemical and microbiological quality of purified water. Microbiological evaluation:- not exceed 100 CFU/ml Avoid the risk of microbial proliferation by circulation of water either at elevated temp.70 °C or l ower temp. 4 °C , use of UV, use of sanitizing agent like chlorine 2) Purified water:-

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schedule M/ part-IC 27 Manufacturing personnel:- wear non- fibre shedding clothing Maintain the homogeneity of emulsion. Primary packaging area:- Temperature of the area:- 3) Manufacturing:-

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1. Mixing & storage tanks [jacketed kettle / SS tank (steam, gas or electrically heated)] 2. Portable mixer 3. Colloid mill or suitable emulsifier / homogenizers or any other suitable equipment. 4. Semi automatic / automatic bottle filling machine 5 . C ap sealing machine 6 . Water still or deionizer 7 . Clarity testing inspection table LIST OF EQUIPMENTS (AS PER SCHEDULE M) Introduction To Dosage Form,disperse system,vol 1,228 28

Flow of material::

Flow of material: B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 29 Paper:-910102 Jignasha R. Bhuria(2009-2010) 29 SS Tank 100-10,000 L Colloid mill 120-12000 L Filtration 14,000 L Distillation 50-2500 L Washing 80-240bottles/M Filling & Sealing 60-80bottles\M Inspection 40-60bootles/M Labelling 250labels/M Pkg conveyor cartoning Steam G.jacketed SS Tank

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Mixing & Storage Tanks Manufactured from SS & is Argon welded. The tank will be mounted on 4 legs with castors for movements. Available from 50-10,000 liters. Pharmaceutical Engineering,C V Subramanyam,1st ed,227 30

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SS Tank with Stirrer With SS steam jacketed & insulation with SS cladding. Different type of stirrer (paddle/ anchor/propeller) available. Electric heating also possible for small scale. Capacity:-100 ltres to 10,000ltrs Pharmaceutical Engineering,C V Subramanyam,1st ed,230 31

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Jacketed kettle / SS Tank (steam, gas or electrically heated) Pharmaceutical Engineering,C V Subramanyam,1st ed,230 32

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Homogenizer Spring Crude mixture inlet Outlet Homogenized liquid Valve cover Valve seating Theory and Practices of Industrial Pharnacy,Lachman,3rd ed,511 33

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Colloid mill Theory and Practices of Industrial Pharnacy,Lachman,3rded,511 34 Superfine grinding and simultaneous emulsifying, dispersing, and homogenizing within one process. Clearance between rotor & stator: 0.001inch Rotor speed: 2800 rpm Continuous and recalculating method of operation possible Jacket is provided for heating or cooling application . Crude mixture inlet Clearance Homogenized liquid Drive shaft ROTER

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Ultrasonifier inlet Orifice Vibrating blade Outlet Theory and Practices of Industrial Pharnacy,Lachman,3rded,511 35

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Bottle washing machine www.pharmaceuticalsmachines.com 36

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Bottle filling machine www.pharmaceuticalsmachines.com 37

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ROTARY PISTON FILLING CUM SEALING MACHINE www.pharmaceuticalsmachines.com 38 Single Operator for Two Operations Prevent Contamination – as immediate sealing of filled bottles Accuracy + 0.5% due to piston dosing principle Electronic liquid level controller & pneumatically regulated control valve

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Bottle I nspection Machine www.pharmaceuticalsmachines.com 39

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Automatic High Speed Labeling Machine www.pharmaceuticalsmachines.com 40 Application - Patch Body Shape of Container: Flat/Elliptical/Oval/Square Size of label: 15 -130 mm Output: 50 -120 containers / minute

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Packing conveyor belt www.pharmaceuticalsmachines.com 41

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Bottle trimming & cartooning machine www.pharmaceuticalsmachines.com 42

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SOP FOR LIQUID MIXING / STORAGE TANK Ensure status label. Ensure that the bottom valve of the tank is closed. Open the top lid of the mixing tank / storage tank provided for loading the material. Transfer the purified water & required material as per BMR of the particular product of the particular batch. Close the lid of the mixing tank / storage tank. Run the stirrer for the time duration mentioned in the respective manufacturing record. Speed of the stirrer can be increased or decreased using speed adjustment knob as per required . After completion of mixing, switch off the stirrer. Affix the status label. How To practices GMP,P.P.Sharma,sop,oral preparation 43

SOP for cleaning the equipments::

SOP for cleaning the equipments: How To practices GMP,P.P.Sharma,sop,oral preparation 44 washed in DM water. immersed in a suitable antiseptic solution washed in running DM water dry.

Continue::

Continue: How To practices GMP,P.P.Sharma,sop,oral preparation 45 Clean the external surface The electric connection Flexible hoses collect around 200 ml of rinse water Affix status label

Packing,Labelling And Storage::

Packing,Labelling And Storage: Depending on the use, emulsions should be packed in suitable containers. Emulsions meant for oral use are usually packed in well filled bottles having an air tight closure. Light sensitive products are packed in amber coloured bottles. For viscous emulsions, wide mouth bottles should be used. B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 46

Continue::

Continue: The label on the emulsion should mention that these products have to be shaken thoroughly before use. External use products should clearly mention on their label that they are meant for external use only. Emulsions should be stored in a cool place but refrigeration should be avoided as this low temperature can adversely effect the stability of preparation. B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 47

Stability of emulsion::

Stability of emulsion: B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 48

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B.M.R. (Batch Manufacturing record) M/s (Name & address of the company) Name of the product………………………………………… (Trade name, if any)………………………………………… (MFR No.)……………………………………………………. Batch No. …………………………Batch size…………….. Date of Expiry………………………………………………… Date of commencement of manufacture…………………… B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 49

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Sr. No. Ingredients as per order of mixing stand- ards Q/C report no. Label claim Quantity required Quantity actually used Remarks 1. 2. 3. 4. 5. 6. 7. 8. Raw materials initially weighed or measured by (attach requisition / issue slip duly signed by stores personal) Weights/Measures counter-checked by I certify that all the equipments and machinery to be used have been examined by me and have been found clean. Sign. TOTAL B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 50

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Date Duration of mixing Mixing Equipment used Specify order of mixing pH of bulk solution Adjusted pH (if needed of bulk solution) B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 51

Filtration::

Filtration: Machine used Actual yield Theoretical yield Whether within limits Q/C report of finished product (Status No. & date and release order) B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 52 Date Duration of filtration

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Date of release Qty. released Date of transfer of finished Product to warehouse Production supervisor Sign. Counter signed ( HOD Q.C.) B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 53

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B.P.R. (BATCH PACKAGING RECORDS) M/S (Name & address of company) Product name Generic name Batch no. Batch size Mfg. Date Exp. Date Container description Precoding of labels / Printing packaging Material examined and verified by Precoded 1. Labels received 2. Carton received B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 54

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Dt Time Personnel responsible for Filling Commenced Filling stopped Chk. of empty bottles Chk. of filled bottles Chk. of labeled bottles Chk. of cartons Labeled claim Precautions taken (Specify) Result of bulk finished Product analysis (Status, report no. & date) No. of refilled bottles B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 55

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Labels cartons Requisitioned / received Used Returned Destroyed Destroyed on (date) Destroyed by Total quantity packed Date of completion Reconciliation of labeling & Packaging materials Packaging in charge Sign. B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 56

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Batch Production in-process Control records M/s (Name & address of company) Name of the product Batch No. Batch Size Date of commencement of manufacture B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 57

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Visual examination of empty washed and dried containers: Date …………………………………………………….. Name of the workers who examined the containers ……………………………………………………………. Total no. of the container examined ..………………… Number of container found defective ………………… Nature of defect ………………………………………… pH of the Bulk solution : Date ……………………………………………………….. pH of bulk solution ………………………………………. Adjusted pH……………………………………………….. (if needed to be adjusted) B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 58

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Date Time Volume found Visual examination of the filled bottles: Date ……………………………………………………………………… Name of the workers who examined the containers ………………… Total no. of bottles examined …………………………………………. Number of bottles found defective ……………………………………. Nature of defects ……………………………………………………….. Net contents in containers: Volume claimed on label .…………………………………………….. Sign. Of Q/C personnel who is Responsible and / or carried out the tests B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 59

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Introduction To Dosage Form,disperse system,vol 3,513 60 VALIDATION PROTOCOL Validation studies are an essential part of GMP & should be conducted in accordance with predefined protocols . Protocol means a document that gives details of: 1. Critical parts of manufacturing process 2. The parameters that should be measured 3. Their allowable range of variability 4. The manner in which the system will be tested Why validate? To conform Manufacturing to cGMP regulations. To avoid the possibility of rejected or recalled batches . To ensure the product uniformity and quality.

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Introduction To Dosage Form,disperse system,vol 3,513 61 Validation can be defined as a procedure that demonstrates a process under standard conditions, is capable of consistently producing a product that meets the established product specifications. Process and procedure should be established on the basis of a validation study and undergo periodic re-validation to ensure that they remain capable of achieving the intended results.

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VALIDATION ( Process Variables) Process Equipme-nts Process variables Properties affected by variables Monitoring output Mixing of liquid Kettle & Tank fitted with agitator Capacity of unit, Shape & position of agitation system, Order of addition, Rate of addition, Fill volume, Mixing speed of agitator, Temperature of liquid, Mixing time. Appearance of liquid, Viscosity of liquid. Potency, Appearance, pH, Viscosity, Specific gravity. Introduction To Dosage Form,disperse system,vol 3,513 62

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Process Equipment Process variables Properties affected by variables Monitoring output Dispersing Homogenizer, Colloid mill, ultrasonic device clearance of rotor & stator, Pressure/rotor speed/power consumption, Feed rate, Temperature, Dispersion time, Order of mixing. Particle size of solids, Viscosity of liquid. Potency, Particle size Distribution, Viscosity, Specific gravity. Introduction To Dosage Form,disperse system,vol 3,513 63

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PRODUCT VALIDATION Major test parameters used for final product testing Appearance pH Viscosity Specific gravity Microbial count Leakage test for filled bottle Check the cap sealing Fill volume determination Particulate matter testing Stress test Introduction To Dosage Form,disperse system,vol 3,513 64

LIQUID OROS SYSTEM (L-OROS): :

LIQUID OROS SYSTEM (L-OROS): Prepared by using HGC or SGC. Bioavailability-enhanced delivery systems Used for hydrophobic drug Enhanced bioavailability Eg . Concerta ®, Ditropan XL®, and Procardia XL® . B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 65

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Question::

Question: How will you prepare qualitative and quantitative layout for liquid dosage form ? (Jan 2010 & April 2010) B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 68 Explain departmental layout with specific requirement of equipments for oral liquid dosage forms.(Jan 11) Explain emulsion manufacturing layout. What are specific GMP requirements of emulsion preparation? Discuss various equipments used in emulsion preparation. SOP for liquid mixing tank & cleaning. Detail validation of the emulsion preparation. Discuss in brief about recent innovations in emulsion preparation

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B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 69 REFERENCE BOOKS: The Theory & Practice of Industrial pharmacy by Leon Lachman. How to practice GMP by P.P. Sharma. CVS Subrahmanyam , Textbook of Physical Pharmaceutics,edition2007,Vallabh Prakashan,PP-395-426 Aulton, Michael E., ed (2007). Aulton's Pharmaceutics: The Design and Manufacture of Medicines (3rd ed.). Churchill Livingstone. pp. 92–97, 384, 390–405, 566–69, 573–74, 589–96, 609–10, 611. ISBN  9780443101083. Ansel’s Pharmaceutical Dosage Forms andDrug Delivery Systems, 9 th edition, pg no. 376 Validation of Disperse System: Pharmaceutical Dosage Form: Disperse Systems: Volume 3 (Part B).

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B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 70 WEBSITE: www.pharmaceuticalmachines.com www.ravipharma.com www.Pharmapedia.com www.wintechpharma.com www.cadmach.com www.baxa.com

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B.K.MODY GOVT.PHARMACY COLLEGE,RAJKOT 71 Thank you

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