Basics of Processing Botanical Products

This section will briefly discuss the preparation of herbal supplements and how this can potentially affect decisions on which products to choose. Botanicals (herbs and phytonutrients) are prepared for manufacturing after growing, harvesting, and drying at specified temperatures in a drying oven. Botanicals are inspected for quality, based on organoleptic tests (the senses of sight, smell, taste, touch) and other scientific methods (TLC, HPLC, GC, bacterial contamination testing, heavy metal testing, etc.) are followed.

Grinding Process
Extraction Processes: A Historical Perspective
Capsules/Tablets

Grinding Process
After the raw material is selected, botanicals are ground into particle size for further manufacturing. Grinding, or comminution, means mechanically breaking down leaves, roots, seeds, or other parts of a plant into particles ranging from large course fragments to very fine powders, depending upon specifications. Grinding is employed in the production of crude herbal products, such as capsules and tablets, as well as in the initial phases of making liquid extracts. Herbs must be reduced in particle size for proper extraction and manipulation to form dietary supplements. The particle size is reduced to allow for more surface area of the herb to be exposed to the solvent and eventually be extracted over time. A company should not grind the herb for an extended period of time before extraction, as reducing particle size will allow more oxygen to interact with the active constituents. Oxidation may occur, potentially destroying some of the active constituents. Some products may be ineffective due to improper grinding.

Extraction Processes: A Historical Perspective
Extraction, from the Latin extractio (to draw out), is the act of withdrawing constituents from an organised structure (plants) by expression, infusion and decoction, distillation, maceration, percolation, or other physical or chemical means by treatment with a solvent (substance that pulls various chemical constituents from the plant material). Heat may be employed in the extraction process to remove the more stable chemicals. The process of extraction is used in making tinctures, liquid extracts, and solid extracts for capsules and tablets.

In the U.S.A. and Australian natural products industry, most extracts utilise alcohol and water mixtures as solvents to remove the soluble compounds from the herb. It is common in other countries to use organic solvents such as hexane or dichloromethane. Many product manufacturers do not extract the herbs themselves or have collaborative ventures with other countries. Some raw materials are purchased from Asia and Europe, where extraction techniques are advanced and are performed for large quantities of product.

In herbal extraction, a known amount of ground herb (usually dried) is placed in an amount of solvent capable of extracting the needed constituents from the plant material. The herb/solvent mixture is placed in a sealed vessel and allowed to macerate (mix) for at least two weeks, depending upon the extraction procedure. The product is then removed from the vessels and pressed to extract all the liquid. The resulting solution is filtered and tested for its various chemical constituents. The liquid can then either be bottled or sold as tincture (liquid extract), or it can be further processed into standardised, encapsulated, or tableted products.

Capsules/Tablets
Powdered extracts and concentrates must be protected from light, oxygen and moisture. This is best accomplished by processing them into solid dosage forms such as granules, tablets, coated tablets and capsules. Preparing medications in a form appropriate for their intended use also permits more accurate dosing. Many companies are now using powdered extracts (both standardised and non-standardised) made from evaporated liquid extracts to produce solid dosage forms. We extract the herb with the appropriate solvents, then concentrate the product until a desired level of activity is reached. The product is now usually spray-dried onto a carrier medium, ground and encapsulated.

Capsules are hard gelatin containers, consisting of a two-part cylindrical shell whose halves are fitted together after the herb and other ingredients (powdered or granulated) have been placed inside. They are purchased in various sizes: 000 (triple naught) is the largest, 00 (double naught) next, 0 (naught), then 1, 2, 3, 4, and 5 being the smallest. The 00 and 0 capsules are the most commonly used sizes. Besides gelatin (from animal tissue), the capsule shell contains glycerin or sorbitol as a softening agent, water, aromatics, dyes, and antimicrobial additives. Vegetable or starch capsules are also available. Soft gelatin capsules are spherical, oval, oblong, or teardrop shaped with a gelatin shell, enclosing semi-solid or liquid contents that must be free of water.

Tablets are made by the compression of powdered or granulated material by tableting machines. Besides the active ingredients (herbs), tablets may contain diluents (excipients) such as binders, lubricants, colouring and flavouring agents, and disintegrators to help the compressed tablet dissolve. Commonly used excipients are magnesium stearate, stearic acid, lactose, and microcrystalline cellulose. There are many important elements, which contribute to the success of fine Pharmanex products. Ingenious formulation, the finest selection or raw materials, state of the art manufacturing, and complete and comprehensive quality control measures insure outstanding products, which are second to none.

Ensuring and maintaining quality products is not the least of these contributing factors. Quality control extends over every step of the production and distribution process. Specific standards are set for different aspects of the product in each production stage. Raw materials are held in quarantine until they meet or exceed all quality requirements. Any failed raw material is returned to the supplier. After mixing raw materials, the product, (still in the mixing vat), is evaluated according to specific standards. At this time the product is also checked to ensure that it is not microbially contaminated. Bulk product will often be stored for several days before filling. The same quality control procedures are followed again before filling begins. After the product has been packaged, representative samples are tested again. Other representative samples of finished product are held and tested at set intervals to insure adequate shelf life.

Quality control measures do not end with production. Upon arrival in the warehouses, product is tested again according to preset standards. All product is held in quarantine until tests are complete, again, several sample products are retained for future testing if necessary. At satisfactory completion of the tests, the shipment can be released to the picking line where it can be used to fill orders.

Pharmanex uses proprietary technology in its manufacturing process to maintain tight quality controls over all stages of product development. The key to consistent quality is the Pharmanex 6S Quality Process, the basis of the company's pharmaceutical-like approach to product development. By applying the process, Pharmanex has consistently met or exceeded standards that are acceptable to the industry. The 6S Quality Process, which includes the elements of selection, sourcing, structure, standardisation, safety, and substantiation, has enabled Pharmanex to become an industry leader in quality and efficacy.

Complete and comprehensive quality control is a priority for Pharmanex and is only briefly described above. More and more resources are committed to this area to ensure and improve the quality of Pharmanex products.

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