Granulation Aggregation

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1 Granulation Aggregation

2 Wet granulation Solvent granulation (crust granules) Binder granulation (sticked granules) Granulation liquid Water Water + alcohol mixture Macromolecular colloidal solution i.e.: starch, gelatine, polividon, cellulose ethers (MC, HEC, HPMC, etc.)

3 Wet granulation Drug(s) + excipient(s) Grinding Blending Agglomeration Granule/Pellet Aggregation Drying Press through sieves (particle size adjustment) Dispersion

4 Wet granulation

5 Melt granulation

6 Melt granulation

7 Melt granulation

8 Melt granulation Advantages Neither solvent nor water used in this process. Good alternative for water sensitive drugs. Fewer processing steps needed since wetting & drying phases eliminated, thus less time consuming There are no requirements on compressibility of active ingredients, entire procedure simple, continuous and efficient. Uniform dispersion of fine particle occurs. Good stability at varying ph and moisture levels. Safe application in humans due to their non-swellable and water insoluble nature. Clinically advantaged dosage forms, such as drug abuse and dose dumping deterrent technology. Sustained, modified and targeted release capabilities. Better content uniformity was obtained from HME process among granules of different size ranges. Reduced number of unit operations. Production of a wide range of performance dosage forms

9 Melt granulation Disadvantages Thermal process (drug/polymer stability). Requires high energy input. The melt technique is such that the process cannot be applied to heat-sensitive materials owing to the elevated temperatures involved. Lower-melting-point binder risks situations where melting or softening of the binder occurs during handling and storage of the agglomerates Higher-melting-point binders require high melting temperatures and can contribute to instability problems especially for heat-labile materials. Flow properties of the polymer are essential to processing. Limited number of available polymer

10 Melt granulation Hydrophylic binders Binder Typical melting range ( C) Gelucire 50/ Poloxamer PEG PEG PEG PEG PEG PEG

11 Binder Melt granulation Hydrophobic binders Typical melting range ( C) Beeswax Carnauba wax Cetyl palmitate Glycerin monostearate Paraffin wax Stearic acid Glyceryl behenate Glyceryl palmitostearate Glyceryl stearate Hydrogenated castor oil Microcrystalline wax Stearyl alcohol 56-60

12 Melt granulation Plasticizers Type Examples Citrate esters Fatty acid esters Sebacate esters Phatalate esters Glycol derivatives Others Triethyl citrate, tributyl citrate, acetyl triethyl citrate, acetyl tributyl citrate Butyl stearate, glycerol monostearate, stearyl alcohol Dibutyl sebacate Dietyl phtalate, dibutyl phtalate, dioctyl phosphate Polyethylene glycol, propylene glycol Triacetin, mineral oil, castor oil

13 Melt extrusion

14 Dry granulation

15 Dry granulation

16 Tasks & Preparations 1. Granule preparation o Pro-C-epT (high shear granulator) o Z-shaped kneader 2. Moisture content determination (analysis of drying process of granules) 3. Grinding, sieve analysis (ball grinder & vibrating sieve) 4. Mixing (rotating cube mixer)

17 Wet granulation Tasks & Preparations Granulatum piracetami (a., b., c.): Piracetam 42.0 g PVP 3.0 g Microcrystalline cellulose 50.0 g a. Aqua purificata 15.0 g b. Aqua purificata 20.0 g c. Aqua purificata 25.0 g Preparation parameters: Impeller (rpm): 1000 RPM Chopper (rpm): 1100 RPM Liquid addition: 10ml/min Pre-mixing: 3 min Pro-C-epT High shear granulator

18 Wet granulation Tasks & Preparations Pellet preparation (a., b.): Avicel PH g Ethylcellulose 4.00 g Lactose g Preparation parameters: Pre-mixing: 3 min Impeller (rpm): 1000 RPM Chopper (rpm): 1100 RPM Liquid addition: 10ml/min Pro-C-epT High shear granulator Total liquid (Aqua purificata): a. 52 ml b. 70 ml

19 Wet granulation Tasks & Preparations Granule preparation I. Solani amylum g Lactose g II. Aqua purificata Solani amylum g 30.0 g Z-shaped kneader Make a suspension with a cold water from the starch. Heat the liquid with water-bath while the starch becomes gelatinous (10-15 min). Cool down the granulating liquid to 40 C and refill the evaporated water. Homogenise the sieved powders, and knead it with small details of granulating liquid in Z-shaped kneader. Break the wet stuff through the granulating sieve IV (1.2 mm). Use oscillating granulator.

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