Formulation Guide

Direct Compression

Pass all components through a 0.8-mm sieve, mix, and press with medium-compression force.

1. Granulate mixture of items 1 and 2 with solution of items 4 and 5 (in a fluidized bed), sieve, add item 6, and press with high-compression force.

2. Compress into 620-mg tablets, using 12-mm biplanar punches.

1. Mix all components, pass through a sieve, and press with high-compression force.

2. The 20-mm biplanar tablet has an average weight of 2.6 g.

1. All of the ingredients are dried at 40.C to 60C to significantly reduce the moisture content of the material.

2. Mix and compress at low forces.

Mix items 1-8 in a V-blender and mix for 15 minutes. Compress at low forces.

1. Sift and mix items 1, 2, 3, and 6.

2. Lubricate with magnesium stearate and fine talc powder.

3. Compress into 200-mg tablets, using 6-mm punches.

1. Mix starch and loratadine to form a uniform mixture

2. Mix remaining excipients (mannitol, aspartame, microcrystalline cellulose, colloidal silicon dioxide, purified talc, magnesium stearate, PVPK-30, sodium starch glycolate) step wise to the uniform mixture of powder.

1. Dry the sodium bicarbonate for 1 hour at 100.C, mix with the other components, pass all through a 0.8-mm sieve,

Mix all components, pass through an 0.8-mm sieve, and press with a compression force of 20 kN.

1. Premix the CBD granule with sodium bicarbonate and Sodium Benzoate. Mix the color with sodium carbonate. Place citric acid in a bowl of a suitable blender.

2. Slowly add 2 mg of water to the citric acid and mix thoroughly to form a moist blend. Add to the blend, in sequence, while mixing, the sodium bicarbonate mix and the sodium carbonate color mix. Mix until uniformly dis-tributed.

3. Compress tablets using suitably sized tooling. Cure the tablets, cool, and package in aluminum foil.

A mixture containing CBDC-75, mannitol, maize starch, and microcrystalline cellulose is blended in a container at the stirrer speed of 14 rpm and under the normal temperature and humidity (25.C, 60% R.H.). Magnesium stearate is added to the premixed mixture. After homogenization, the precompression mixture is compressed on a rotary compression machine to form flat (cylindrical) or oval-shaped tablets of 130 mg in the mas

1. Pre-mix CBDC-75 with one-third quantity of the microcrystalline cellulose and one-half the quantity of the anhydrous lactose in a blender for 5 minutes at 20 rpm.

2. To the premix is added the remaining two-thirds of the microcrystalline cellulose and the remaining one-half of the anhydrous lactose. Blend for 10 minutes at 20 rpm.

3. Add croscarmellose sodium to the blended powders in step 2 and mix for 5 minutes at 20 rpm.

4. Add item 4 to the mixture after passing it through a 90-mesh screen and blend for an additional 5 minutes at 20 rpm.

5. Compress into 400 mg tablets, using a suitable punch.

1.Gum base powder and active ingredient (Caffeine salicylate) are mixed well in mortar.

2. Soy lecithin, sorbitol, mannitol, sweetner, and L-menthol are added to gum base and active mix

3.After thorough mixing, add lubricant and glidant.

1. Screen items 1, 7, and 8 separately through a 40-mesh sieve.

2. Blend items 1 to 6 and 9 in a V-shaped blender, and mix for 3 minutes.

3. Add item 8 to the blender and mix for another 5 minutes.

4. Compress, using 7 kg pressure and 3/8-in., flat, bevelededge punches to produce tablets with an average weight of 311 mg.

1. Pass items 1 to 4 through a 250 mesh screen and blend for 10 minutes.

2. Add item 5, blend for 1 minute, and pass the mixture through a #11 sieve.

3. Compression at low compression force.

1. Blend Dry plant extract and excipients, except magnesium stearate, for 12 minutes by tumbling.

2. Add corresponding amount of magnesium stearate and blended for another 4minutes.

3. Compress for 5 seconds.

Tocopheryl acetate dry powder 50%, spray-dried with gelatin

1. Mix all components, and press with a low-compression force.

2. Compress into 518-mg tablets, using 12-mm biplanar punches.

1. Mix all components and pass through a 0.5-mm sieve.

2. Press to tablets at 66 mg.

1. Mix all components except Magnesium stearate and blend in a V-blender for 10 minutes.

2. Add Magnesium stearate and mix an additional 1 minute and compress.

1. Blend half of the Starch 1500 with the fumed silica and CBD Granulate for 5 minutes.

2. Pass this mixture through a 40-mesh screen and return to blender.

3. Add the remaining starch 1500 to the material in step 1 and blend for 5 additional minutes.

4. Add the microcrystalline cellulose (MCC 102) and stearic acid to the material from step 2 and blend for an additional 10 minutes.

5. Add the magnesium stearate to the material from step 3 and blend for an additional 5 minutes.

1. Prepare with wet granulation method, using 9% PEG (Polyethylene glycol) 6000 as lubricant, polyvinylpyrrolidone 5% as binder, mannitol as filler, 1% sodium chloride as glidant and 2% sodium lauryl sulphate as lubricant.

1. Mix all components, pass through an 0.8-mm sieve.

2. Compress into lozenge, using 8-mm biplanar punches.

1. All of the ingredients are dried at 40.C to 60C to significantly reduce the moisture content of the material.

2. Mix and compress at low forces.

1. Mix Amoxicillin Trihydrate, Health in Gum® PWD-01, and Menthol in porcelain mortar.

2.Pass through 100# sieve

3.Mix blend with AEROSIL® fumed silica, Talc, and Aspartame for 5 minutes.

4.Keep in freeze for 30 minutes.

1. Granulate mixture of items 1 to 4 with item 5, and pass through a 1-mm sieve.

2. Dry until a relative powder humidity of 90% is reached.

3. Add solution of items 6 and 7, and pass again through a 0.8-mm sieve.

4. Dry the granules, and press into 481-mg tablets using lowcompression force and 12-mm planar punches

5. Dry the obtained tablets.

Add crospovidone (6.4% w/w) as a disintegrant.

Mix all components, pass through a 0.5-mm sieve, and press with low compression force.

1. Discharge all the ingredients through a 0.5-mm sieve, and mix for 10 minutes.

2. Press into 132-mg CBD tablets using medium-compression force and 8-mm biplanar punches.

1. Pass all components through an 0.8-mm sieve, mix, and press with low-compression force.

2. Compress using 12-mm biplanar punches.

3. Crospovidone may be omitted and the tablet weight adjusted.

Mix all ingredients for 15 minutes and compress al high forces.

Direct Compression

CBDC-75 is first blended with one-third of microcrystalline cellulose 102 and with one-half of anhydrous lactose. The premixture obtained is then blended with both remaining excipients and it is mixed again. Sodium salt of carmellose is added under mixing to be followed with magnesium stearate to finish the mixture blending. When homogenized by forth mixing the mixture is subjected to the compression.

1. Add CBDC-75, gelatin, and croscarmellose sodium, one item at a time, in a suitable blender, and mix for 15 minutes.

2. Add talc and magnesium stearate, and mix for an additional 5 minutes.

3. Compress into 230-mg tablets, using 6-mm punches.

Pass Mannitol, Sodium Starch Glycolate, and Croscarmellose Sodium were through a 100 mesh screen prior to mixing.

Mix Ondansetron Hydrochloride to sieved blend of powder.

Add and mix mint Flavor, Aerosil®, and Magnesium Stearate

1. Mix all ingredients except magnesium stearate thoroughly using double cone blender for 15 minutes. Set the speed of the blender to 35 revolutions per minute.

2. Compress mixed excipients into a 10mm slug or tablets using a rotary tableting press.

3. Crush slug into small granules using an oscillating granulator. The granules produced will be used for final compression.

4. Add magnesium stearate to the formulation granules and mix again using double cone blender at 35 revolutions per minute for 15 minutes.

In a mixer, pour and mix for 5 minutes in 6 steps:

1. Tartaric acid and sodium bicarbonate

2. Ascorbic acid and sodium ascorbate

3. Sorbitol DC, flavor and sodium saccharinate

4. A third of PEG 6000 and sodium benzoate

5. A third of PEG 6000 and sodium benzoate

6. A third of PEG 6000 and sodium benzoate. The powder is ready to be compressed.

1. Pass CBDC-75 granulate, sodium ascorbate, sorbitol, lactose, FD&C Yellow Dye, microcrystalline cellulose, silica gel, flavors, and sodium cyclamate through a 420-mircrogram screen.

2. Using a comminuting mill, pass the coarse granules through a 420-microgm screen (knives forward, medium speed).

3. Transfer milled materials to a suitable blender, and blend for 5 minutes.

4. Screen the magnesium stearate by hand through an 840-microgm screen, and transfer to blender.

5. Mix for 1 minute.

6. Compress using 18-mm standard concave punches.

Pass all ingredients through a 0.8-mm sieve and press with high-compression force.

1. Mix all ingredients except 4 for 10 minutes.

2. Add Magnesium Stearate and mix for 1 minute.

3.  Compress using low compression forces.

Mix all components, pass through an 0.8-mm sieve, and press with medium-compression force.

1. Pass item 2 through 0.7-mm sieve and collect in a stainless steel container.

2. Charge half quantity of step 1 in a tumbler.

3. Pass items 1 and items 3 to 5 through 0.5-mm sieve and collect in a container.

4. Add 15% Mannitol from step 1 to step 3 and mix well.

5. Compress at medium force.

Active ingredient and all additives are homogeneously blended using geometric dilution after passing through 500 micron screen sieve.

PEG 3350 is added to the mixture.

1. Pass all components through an 0.8-mm sieve and mix. Press with medium- or high-compression force at maximum 30% relative humidity.

3. Use 12-mm biplanar punches for 602-mg tablets.

1. Mix all components except Magnesium stearate and blend in a V-blender for 10 minutes.

2. Add Magnesium stearate and mix an additional 1 minute and compress.

Mix all items for 15 minutes, pass through a sieve, add Magnesium Stearate and mix for an additional 1 minute. Press with medium compression force.

1. Mix aluminum hydroxide, magnesium hydroxide, sucrose, and mannitol in a suitable blender.

2. Add povidone and glycerin, use this to moisten the mix of the first four ingredients.

3. Granulate by passing through a 14 mesh screen.

4. Dry at 60.00 to 65.56 °C.

5. Size through a 20-mesh screen.

6. Add and thoroughly mix magnesium stearate, fumed silica, and peppermint oil.

The components of each formulation were weighed, sieved, and mixed for 5 minutes

1. Blend all ingredients in a twin-shell blender for 10 minutes.

2. Compress into 153 mg tablets.

A mixture containing CBDC-75, Lactose, and Prosolv 50 is blended in a container at the stirrer speed of 14 rpm and under the normal temperature and humidity (25.C, 60% R.H.). Magnesium stearate is added to the premixed mixture. After homogenization, the precompression mixture is compressed on a rotary compression machine to form flat (cylindrical) or oval-shaped tablets of 355mg tablets

1. The CBDC-75 Granulate is coated with a layer of a taste-masking composition with a thickness of about 3 to 10 micrograms. The coating should be substantially free of cracks, holes, and other imperfections when examined under a scanning electron microscope at 100 to 500 magnification.

2. Charge items 1 to 7 in a suitable blender and mix for 20 minutes.

3. Add item 8 to step 2 and blend for 2 minutes.

4. Compress the appropriate quantity.

1. Pass all components through an 0.8-mm sieve, mix, and press with very low-compression force (4 kN).

2. Compress into 202-mg tablets, using 8-mm biplanar punches.

3. This is a very low active ingredient formulation (5 mg), if content uniformity is a problem, prepare a premix of the active ingredient with a small part of the lactose monohydrate before mixing with the other components of the formulation.

Dry excipients are blended, and the dry mix is moistened with an appropriate amount of 4.7% (w/w) microcrystalline cellulose.

The wet mass is passed through sieve number 16.

The granules are dried in a hot air oven at 40 ± 2°C for 2 hours.

The wet granules are re-sieved through number 14 sieve.

1ml of S. officinalis essential oil is mixed with sorbitol and dried in the oven for 1 min at 40 ± 2°C.

Powder containing essential oil is added to dried granules.

The granules are lubricated with 3% (w/w) magnesium stearate.

Mint extract is added as a flavoring agent.

Propylparaben is added as a preservative and antibacterial agent.

Prior to blending, pass ingredients through a 20 mesh sieve.