MANUFACTURING OF NUTRACEUTICAL & HERBAL TABLETS
The design and manufacture of tablets is a complex multi-stage process whereby Plant Manager ensure that the correct amount of drug substance in the right form is delivered at the appropriate time, at the proper rate and in the desired location with its chemical integrity protected to that point. Most drug substances do not possess the required properties which give satisfactory flow from the hopper to the die cavity of tablet presses. As a result, they are subjected to pre-treatment either alone or in combination with suitable excipients to form free-flowing granules that lend themselves to tableting.
Tablets are commonly manufactured by wet granulation, dry granulation or direct compression. These methods may be considered to consist of a series of steps (unit processes) – weighing, milling, mixing, granulation, drying, compaction, (frequently) coating and packaging. Regardless of the method used the unit processes – weighing, milling and mixing, are the same; subsequent steps differ.
OUR PRIMARY GOALS OF TABLET MANUFACTURING PROCESS
The primary goals include:
- To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use.
- To formulate tablets those are uniform in weight and in drug content.
- To formulate tablets those are bioavailable according to indication requirements.
- To formulate tablets those are chemically and physically stable over a long period of time.
- To formulate tablets that have elegant product identity which is free from any tablet defects?
FACTORS THAT INFLUENCE THE CHOICE OF MANUFACTURING PROCESS USED DURING TABLET FORMULATION
In general, the choice of formulation process employed during tablet manufacture is dependent upon such factors as:
- Compression properties of the Active Pharmaceutical Ingredient (API)/ drug substance.
- Physical and chemical stability of the API during the manufacturing process.
- Particle size of the formulation ingredients.
- Availability of the necessary processing equipment.
- Cost of the manufacturing/formulation process.
PERSONNEL REQUIREMENTS DURING MANUFACTURE OF NEUTRACEUTICAL & HERBAL TABLETS
- Production pharmacists/ supervisors
- Manufacturing chemist
- Analytical chemist
- Quality assurance manager
- Machine operators
- Mechanics
TABLET MANUFACTURING EQUIPMENT/ MACHINES
Common equipment used in pharmaceutical tablet manufacturing includes:
- Size reduction equipment/ commination equipment e.g., hammer mill, vibration mill, roller mill, pin mill, fluidized energy mill, end-runner mill, edge-runner mill, cutter mill and ball mill.
- Weighing balance/ balances e.g., bulk weighing balance (weighs in kilogram), electronic weighing balance (weighs in grams and milligrams).
- Mixing equipment e.g., pneumatic mixers (air-mix mixer or air-driven mixer), diffusion/ tumbling mixers (e.g., V-blender, double cone blender, cubic mixer, drum blender), convective mixers (e.g., ribbon blenders, orbiting screw mixers, horizontal high-intensity blenders, planetary blenders, diffusion mixer with intensifier bar/agitator, Forsberg blenders, horizontal double arm mixers, vertical high-intensity mixer).
- Granulators e.g., rotating shape granulators, mechanical agitator granulators (e.g., ribbon or paddle blender, sigma blade mixer, planetary mixer, orbiting screw mixers), high-shear granulator, fluidized bed granulator, dry granulator etc.
- Dying equipment e.g., spray dryer, rotary dryer, fluidized bed dryer etc.
- Tableting machine – single punch tablet press and multi-station/ rotary tablet press (e.g., High-speed rotary tablet machines and multi-layer rotary tablet machines).
- Quality control equipment e.g., disintegration equipment (Manesty single unit disintegrating apparatus or Erweka multiple unit disintegrating apparatus), USP Dissolution Tester, Tablet Hardness Tester, Tablet Thickness Tester, Tablet Friability Testers etc.
- Coating and polishing machines for coated tablets e.g., standard coating pan, perforated pan, fluidized bed/ Air suspension coating system etc.
- Packaging machines e.g., blister packaging machines, strip packing machine, aluminium foil packaging machine, etc.
Tablet Manufacturing Equipment continues to improve in both production speed and uniformity of the tablets compressed.
STEPS INVOLVED IN TABLET FORMULATION/ PROCEDURE FOR MANUFACTURING TABLETS
Dispensing: Each ingredient in the tablet formula is weighed and accurately dispensed as per dose. This is one of the critical steps in any type of formulation process and should be done under technical supervision.
Sizing: Formulation ingredients must be in finely divided form, otherwise, size reduction should be carried out for better flow property and easy mixing.
Powder blending: Powders are mixed using a suitable blender to obtain a uniform and homogeneous powder mix. The drug substance and excipients are mixed in geometric dilution.
Granulation: Here small powder particles are gathered together into layers, and permanent aggregates to render them into free-flowing states.
Drying and dry screening: Screened wet granules need to be dried for a particular time period in tray dry or fluid bed dryer at controlled temperature not exceeding 550C. Dried granules are screened through the appropriate mesh screen.
Tablet compression: This step involves the compression of granules into a flat or convex, round, oblong, or unique shaped, scored or unscored tablets; engraved with an identifying symbol and/ or code number using tablet press.
Coating: Tablets and granules are coated if there is need to mask the unpleasant taste/odour of some drug substance or to increase the aesthetic appeal of uncoated tablets as well as to modify the release or control the release of drug substance from tablets. This is achieved by enclosing or covering the core tablet or granules with coating solutions.
Some of the steps above are skipped depending on the manufacturing process used during tablet formulation.
Tablets Manufacturing
Approved Form-7 Generic Formulations that we Manufactured
| Product Name | Generic NAME |
|---|---|
| Salbion's Annovit - M Tablets (Neutra) | Each tablet contains: Vitamin - B1 (USP) ……………….......... 1.5 mg Vitamin - B2 (USP) ……………….......... 1.5 mg Vitamin - B5 (USP) ………………........... 10 mg Vitamin - B6 (USP) ………………........... 50 mg Vitamin - B9 (USP) …………………......... 5 mg Vitamin - B12 (USP) ……………............. 1 mg Vitamin - C (USP) ………………............ 60 mg Vitamin - H (USP) ……………….......... 300 mg Niacin (USP) ……………………….......... 20 mg (USP Specification) |
| Salbion's Bontin Tablets (Neutra) | Each tablet contains: Calcium(USP) …………....................... 500 mg Magnesium Stearate (USP) ……………. 100 mg Zinc Oxide (USP) …………………………. 5 mg Vitamin - D3 (USP) ……………………... 200 IU (USP Specification) |
| Salbion's CalcWorld C Tablets (Neutra) | Each tablet contains: Calcium Lactate Gluconate (USP) … 1000 mg Vitamin - C (USP) …………………….... 500 mg Calcium Carbonate (USP) ……………. 327 mg (USP Specification) |
| Salbion's Cirol - D3 Tablets (Neutra) | Each tablet (650 mg) contains: Vitamin - D3 (USP) ………………… 50,000 IU (USP Specification) |
| Salbion's Dicemine - F Tablets (Neutra) | Each tablet contains: Glucosamine Sulphate (USP) ………. 500 mg Methylsulfonyl Methane (USP) …… 166.6 mg Chondroitin Sulphate (B.P) ………… 100 mg Vitamin - D3 (USP) ……………………. 1000 IU (USP Specification) |
| Salbion's Kalzim - D Tablets (Neutra) | Each tablet (1100 mg) contains: Calcium Carbonate (USP) ………….. 1250 mg Vitamin - D3 (USP) ………………….... 200 IU (USP Specification) |
| Salbion's K-Cytrate Tablet (Neutra) | Each tablet contains: Potassium Citrate (USP) …………… 1080 mg (10 mg eq. per Tablet) (USP Specification) |
| Salbion's Kin - D Tablets (Neutra) | Each tablet contains: Vitamin - D3 (USP) …………….…… 200,000 IU (USP Specification) |
| Salbion's PharmAid Plus Tablets (Neutra) | Each tablet (1100 mg) contains: Panax Ginseng Ext. (MS) …………... 20 mg Vitamin - E (USP) ……………………..... 2 mg L - Arginine (USP) ……………............. 50 mg Selenium (USP) ……………............... 32 mcg Withania Somnifera (USP) ……………. 50 mg Tribulus Teristris (JP) …………….…. 250 mg Ginkgo Biloba Ext. ……………………. 20 mg Zinc Oxide (USP) ………………..……... 10 mg Eurycoma longifolia (MS) …………… 50 mg (USP Specification) |
| Salbion's Ver-C Tablets (Neutra) | Each tablet (4.5 g) contains: Calcium Carbonate (USP) …………… 364 mg Vitamin - C (USP) ……………............ 1000 mg (USP Specification) |
| Salbion's Vilmen Tablets (Neutra) | Each tablet (1100 mg) contains: Vitamin - B1 (USP) ……………….……..... 5 mg Vitamin - B2 (USP) ………………..…..... 1.4 mg Vitamin - B3 (USP) ………………...…..... 16 mg Vitamin - B5 (USP) ………................... 6 mg Vitamin - B6 (USP) ………................... 5 mg Vitamin - B7 (USP) …………………...... 25 mcg Vitamin - B9 (USP) ………………….... 200 mcg Vitamin - B12 (USP) ……………….…... 50 mcg (USP Specification) |
| Salbion's Verbon Tablet (Neutra) | Each tablet (1100 mg) contains: Calcium Carbonate (USP) ……….. 600 mg Cholecalciferol (USP) ……………….. 400 IU Zinc (Zinc Sulphate) (USP) ………... 15 mg Copper Sulphate (USP) …………...... 1 mcg Magnesium Oxide (USP) …………. 75 mg (USP Specification) |
| Salbion's Maltoze Tablets (Neutra) | Each tablet (650 mg) contains: Iron Polymaltose 100 mg eq. to elemental iron (USP) ………………………….……. 33 mg Folic acid (USP) …………….………. 0.35 mg Vitamin - C (USP) …………………… 50 mg (USP Specification) |
| Salbion's Vefol-F Tablets (Neutra) | Each tablet (170 mg) contains: L - Methylfolate ……………………. 400 mcg (USP Specification) |
| Salbion's Viefol Tablets (Neutra) | Each tablet (170 mg) contains: L - Methylfolate …………………….. 400 mcg Vitamin - B12 ………………………… 2.4 mcg |
| Salbion's Calci-Lock Tablet (Neutra) | Each tablet ( 1200 mg) contains: Calcium (as Dicalcium Phosphate) .. 600 mg Magnesium Stearate …………………… 50 mg (Eq. to elemental Magnesium …… 2 mg ) Zinc Oxide ………………………………..10 mg (Eq. to elemental Zinc ……………….8 mg ) Vitamin - D3 ……………………………...100 IU |
| Salbion's Staq Tablet (Neutra) | Each tablet (800 mg) contains: Co Enzyme Q10 ……………….... 100 mg |
| Mynotol Tablet (Neutra) | Each 2 tablets (1200 mg) contains: Myo - Inositol ………………………... 1000 mg L- Methyl Folate ……………………..... 100 mcg Vitamin - D3 ……………………….….. 1000 IU |
| E-400 Tablets (Neutra) | Each tablets ( 650 mg) contains: Vitamin - E ………………………….. 400 IU |
| DG-Tec Tablet (Neutra) | Each tablet (1200 mg) contains: Glucosamine HCl ………………… 250 mg MSM …………………………..…….... 50 mg Chondroitin sulfate ………….…... 25 mg Aloe Vera powder (Aloe Barbadensis) …………………………………………... 10 mg |
| Cartiglu Tablet (Neutra) | Each tablet (1100 mg) contains: Calcium Carbonate ……………….... 400 mg Vitamin - D3 ………………………….... 100 IU Zinc Sulphate (Eq. to elemental Zinc .. 5 mg) ………………………………………….. 11.11 mg Magnesium oxide (Eq. to elemental Magnesium….150 mg) …………. 250 mg |
| NMT Tablet (Neutra) | Each tablet (1100 mg) contains: Tribulus Teristris …………………... 300 mg Shilajit ………………………………. 25 mg |
| Flexibon Tablet (Neutra) | Each tablet (1400 mg) contains: Glucosamine HCl …………….…... 750 mg Chondroitin Sulfate …………….…... 350 mg Methyl Sulfonylmethane …………….. 200 mg |
| Senvit-M Tablet (Neutra) | Each tablet (1100 mg) contains: Vitamin D (as D3) …………………….…… 200 I.U Vitamin - C …………………………….…… 70 mg Vitamin - B1 ………………………………… 4 mg Vitamin - B2 ………………………............. 2 mg Vitamin - B3………………………………….. 20 mg Vitamin - B6…………...................... 10 mg Folic acid ……………………………...…… 400 µg Vitamin - B12 ………………………………. 6 µg Biotin………………………………………... 150 µg Pantothenic acid ………………………….…. 6 mg Magnesium Sulphate ……………………. 150 mg Iron Sulphate ………………………….…. 120 mg Zinc Sulphate …………………......... 15 mg |
| Maxwel Tablet (Neutra) | Each tablet (1100 mg) contains: Vitamin - A ………………………………… 800 µg Vitamin - E…………………………………. 10 mg Vitamin - D3 ………………………………. 200 µg Vitamin - C ………………………………… 10 mg Folic acid …………………………………. 200 µg Vitamin - B1 ………………………………… 2 mg Vitamin - B2………………………………… 1.5 mg Vitamin - B3 ………………………… 16 mg Vitamin - B6 ………………………… 1.5 mg Zinc Oxide (Elemental Zinc)………… 5 mg Vitamin - B12………………………… 2.5 µg Chelated Iron (as Iron Bisglycinate … 5 mg Manganese (as Manganese Sulphate) ... 2 mg Calcium ( as Calcium Carbonate)…… 200 mg |
| Tizip Syrup (Herbal) | Each 10 mL contains extracts of: Emblica Officinalis ……………… 1.875 mg Achillea Millefolium ………….. 1.875 mg Elettaria Cardamomum ……… 1.875 mg Tribulus Teristris………………… 1.875 mg Terminalia Chebula ……………. 1.875 mg Chichorium Intybus ……….…. 1.875 mg Piper Longum ………………... 1.875 mg |
| Seronate Tablet (Neutra) | Each tablet (650 mg) contains: Iron Bisglycinate ( Equivalent to Elemental Iron 30 mg ) …………………………… 150 mg Vitamin – C ……………………….. 120 mg |
| Meconex Tablets (Neutra) | Each tablet contains: Vitamin – B12 ………………... 1000 mcg Folic acid …………….………… 400 mcg |
| Quinz Tablet (Neutra) | Each Tablet contains: Coenzyme Q 10 (USP) ………………. 50 mg |
| Calgimax Tablet (Neutra) | Each Tablet contains:- Calcium……………………………... 500 mg Vitamin D3……………………............. 4 mg Vitamin K2 …….......................... 25 mcg Ascorbic acid………....................... 50 mg Iron (as Ferrous Fumarate) ………... 2 mg Pyridoxine………….......................... 10 mg Zinc Citrate………............................... 5 mg Magnesium (as Oxide)….………………..32 mg |
| Sanodic Tablet (Neutra) | Each Tablet Contains: Cascara Sargada Extract (USP) ……13.5 mg |
| Mecob-F Tabelt (Neutra) | Each Tablet Contains: Mocobalamin (USP) ……………….. 750 mcg Folic acid (USP) ……………………. 5 mg |
| V-C-C Forte Effervescent Tablet (Neutra) | Each effervescent tablet contains: Calcium Lactate gluconate (USP) … 1000 mg Calcium Carbonate (USP) ……….. 327 mg |
Tablets
