PILOT PLANT SCALE-UP TECHNIQUES OF DRY SYRUPS

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PILOT PLANT SCALE-UP TECHNIQUES OF DRY SYRUPS:

PILOT PLANT SCALE-UP TECHNIQUES OF DRY SYRUPS MANMOHAN M.PHARM (PHARMACEUTICS) NIMS INSTT. OF PHARMACY NIMS UNIVERSITY.

PILOT PLANT SCALE UP STUDIES: INTRODUCTION:

PILOT PLANT SCALE UP STUDIES: INTRODUCTION 2

WHAT DO PILOT SCALE AND SCALE-UP MEAN ? :

WHAT DO PILOT SCALE AND SCALE-UP MEAN ? 3

WHAT IS THE NEED: :

WHAT IS THE NEED: Some dry syrups are dry mixtures that require the addition of water at the time of dispensing. Inadequate chemical stability of the drug in aqueous vehicle. To avoid the physical stability problems like viscosity changes, conversion of polymorphic form, incompatibility, crystal growth, caking. Transported without regards to seasonal temperatures. 4

CHARACTERISTICS FOR DRY SYRUPS::

CHARACTERISTICS FOR DRY SYRUPS: Powder blend must be a uniform mixture of the appropriate concentration of each ingredient . During reconstitution, the powder blend must disperse quickly and completely in the aqueous vehicle . Reconstituted suspension must be easily re-dispersed and poured by the patient to provide accurate and uniform dose . Final product must have an acceptable appearance, odor and taste . 5

FORMULATION::

FORMULATION: SUSPENDING AGENT: These are used to prevent sedimentation. E.g.: - methyl cellulose - carboxymethyl cellulose - hydroxyethyl cellulose - HPMC - polyvinyl pyrrolidone - poloxamer - guar gum etc. 6

WETTING AGENT::

WETTING AGENT: A substance that reduces the surface tension of a liquid. E.g.: - polysorbate 80 - polysorbate 20 - sorbitan monolaurate - sorbitan monooleate - poloxamer 188 - sorbitan monostearate etc. 7

ANTIOXIDANTS::

ANTIOXIDANTS : These are used to maintain product stability by being oxidized . E.g.: - Butylated Hydroxy Toluene (BHT ) - Butylated Hydroxy Anisole (BHA ) - Ascorbic acid etc. BUFFERING AGENTS: These are used to maintain the pH of the product . E.g.: - Citrate - Gluconates - Lactates etc. 8

SWEETENING AGENTS::

SWEETENING AGENTS: These are used to provide sweet taste to the formulation. E.g.: - Sucrose - Sorbitol - Saccharin, and it’s salts - Aspartame - Acesulfame –K etc. 9

FLAVOURING AGENTS::

FLAVOURING AGENTS: These agents used to impart flavour to the formulation. E.g.: i) natural: - peppermint - lemon oils ii) artificial: - butterscotch - raspberry - liquorice - apricot - vanilla etc. 10

PRESERVATIVES::

PRESERVATIVES: They prevents an increased risk of contamination by microbial pathogens. E.g.: - Na Benzoate - Parabens etc. COLORING AGENTS: E.g.: - titanium dioxide (white) - amaranth (red) - tartarazine (yellow) - caramel (brown) - chlorophyll (green) etc. 11

PROCESS OF MANUFACTURING::

PROCESS OF MANUFACTURING: Recommended guidelines for production of dry powder: Efficient mixing process should be used. Determine an adequate duration of mixing. Avoid excess heat and moisture during mixing. Temperature and humidity should be maintain ( 70° C at ≤ 40% RH ). Finished batch should be protected from moisture. 12

PREPARATION OF DRY POWDER MIXTURE::

PREPARATION OF DRY POWDER MIXTURE: Powder Blends. Granulated Products. Combination Products . 13

POWDER BLEND::

POWDER BLEND: Mixing the ingredients of the dry mixture in powder form . Ingredients present in small quantities may require a two stage mixing operation . Mixer should rapidly and reliably produce a homogeneous mixture. ADVANTAGES : - less equipments and energy is required. - less chemical and stability problems because no heat or solvents are used . - low moisture content can be achieved in dry mixture . 14

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DISADVANTAGES : - p rone to homogeneity problems – Particle size and Powder flow. - loss of the active ingredient during mixing. - potent drug used in very low concentrations. 15

GRANULATED PRODUCTS::

GRANULATED PRODUCTS: Wet granulation process is used and granulating fluid is water or an aqueous/non aqueous binder solution . Drug can be dry blended with other ingredients or it can be dissolved or suspended in the granulating fluid . Solid ingredients are blended and massed with granulating fluid in a planetary mixer . Wet mass is formed into granules : Vibratory sieve, Oscillating granulator or mill. Granules dried in a tray oven or Fluid bed dryer. Dried granules screened in a vibratory sieve or oscillating granulator to break up or remove aggregates or granules . 16

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ADVANTAGES : - improved appearance. - improved flow characteristics. - less segregation problems. - less generation of dust during filling operations . DISADVANTAGES : - more equipments and energy is required. - difficult to remove the last traces of granulating fluid which reduces the stability. - uniform granulation is necessary, excess of very small particles, or fines, will result in rapid segregation . 17

COMBINATION PRODUCT::

COMBINATION PRODUCT: Less energy and equipments for granulation may be required if majority of the diluents can be added after granulation. Heat sensitive ingredients, such as flavors can be added after drying of granules. Firstly the ingredients are granulated and blend the remaining ingredients with the dried granules before filling into container . 18

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ADVANTAGES : - cost is very less. - heat sensitive ingredients are used. DISADVANTAGES : - risk of uniformity. - particle sizes of various fractions are non uniform. - segregation of granules or ingredients can takes place. 19

PRODUCTION AREA::

PRODUCTION AREA: 20

EQUIPMENTS: DOUBLE CONE POWDER BLENDING MACHINE::

EQUIPMENTS: DOUBLE CONE POWDER BLENDING MACHINE: 21

POWDER FILLING MACHINE::

POWDER FILLING MACHINE : 22

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CAPPING MACHINE: 23

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LABELLING MACHINE: 24

STABILITY TESTING::

STABILITY TESTING: Samples of the dry syrups are stored in containers at room temperature, 37 ° C and 45°C . Viscosity. Homogeneity. pH. Sedimentation volume. Ease of redispersion. 25

CHEMICAL STABILITY::

CHEMICAL STABILITY: Chemical stability should be determined in both the dry mixture and reconstituted suspension. Stability evaluations of reconstituted oral suspensions should be carried out in a container of the same material and size, in which the product is marketed. Effectiveness of the preservative is determined. Drug products are often exposed to elevated temperatures for the determination of a shelf-life i.e. accelerated stability studies. 26

PHYSICAL STABILITY::

PHYSICAL STABILITY: Physical stability should evaluate both the dry mixture and reconstituted suspension. Common evaluations on reconstituted suspensions include sedimentation volume and ease of redispersion. Exposure to a cycle of temperature changes. (Freeze and Thaw ). 27

QUALITY CONTROL::

QUALITY CONTROL: FREEZE- THAW TEST: Freeze-Thaw test conducted by placing the sample in a freezer for 18 hours followed by thawing at room temperature for 4 to 6 hours. Evaluate the appearance and conduct any other appropriate tests at this time. Repeat the Freeze-Thaw cycle for up to 10 times. 28

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VISUAL INSPECTION: With visual inspection, the ingredients and the final products are carefully examined for purity and for appearance . Physical appearance of products for patient adherence and compliance is critical so it should be: Good looking Elegance in appearance 29

LIGHT TRANSMITTANCE TEST::

LIGHT TRANSMITTANCE TEST: A light transmittance meter is a newer tool that is used to check syrup color. In a light transmittance meter, a syrup sample is checked for color by passing light through the sample. The percent of light transmission is compared to light transmission rates set for different grades. When using this, you need to be sure that there are no fingerprints on the syrup test bottle and that the syrup sample has no bubbles or cloudiness. Any of these conditions may diminish the light that is transmitted through the sample and therefore lowers the grade of the sample . 30

pH MEASUREMENT::

pH MEASUREMENT: The measurement and maintenance pH is also very important step in the Quality control testing . Generally there are 2 different types of methods used in the measurement of pH. 31

METHODS FOR PH MEASUREMENT::

METHODS FOR PH MEASUREMENT: The simplest and cheapest is to dip a piece of pH paper into the sample. The paper is impregnated with chemicals that change color and the color may be compared to a chart supplied with the paper to give the pH of the sample. If greater accuracy is required a pH meter should be used.  A typical pH meter consists of a special measuring  glass electrode connected to an electronic meter that measures and displays the pH reading. 32

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FULL-SCALE STABILITY: Final formulation should be placed in the container for marketing and should be stored at 2° to 5°, RT, 37°, and 45°C. 33

MARKETED PRODUCTS::

MARKETED PRODUCTS: 34

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REFERENCE::

REFERENCE: Kulshreshtha Alok K., Singh Onkar N., Wall Michael G., Pharmaceutical Suspensions: Formulation Development and Manufacturing, page no. – 164-165. Gad Shayne C., Pharmaceutical manufacturing handbook: production and processes, Volume 10, page no - 314 – 330. 37

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