Narrative of Operation and General Information
Nutri-West manufactures therapeutic nutritional products for licensed healthcare professionals. These products are manufactured in unit dose forms namely tablets, capsules and topical gels. Our in-house raw materials consist of glandulars, vitamins, minerals, enzymes, botanicals and amino acids. All raw materials used in the manufacturer of our products are supported by a certificate of analysis, which guarantees by the raw materia manufacturer, their potency. All Raw materials are sent to an independent laboratory for analysis and Certificate of Analysis verification. Raw materials are received and are designated a Nutri-West receiving (lot) number. Retained samples are taken and identified. The containers are identified with a commodity number and a Nutri-West lot number, green tagged, to supply visual evidence that all of the above has in fact been done and then stored in an environmentally-controlled warehouse. NutriWest manufacturing is run and governed under the rules of the GMP, (Good Manufacturing Practice Act), and we are inspected at regular intervals by the Wyoming Food and Drug Administration and the Federal Food and Drug Administration (FDA).
Production of Products is Achieved as Follows:
- A copy of the master batch record is made.
- A logged production lot number is issued.
- An envelope is identified for production, which will contain all record documentation for that product. Each record is identified by name, product number and now new lot number. These records are as follows:
- The batch production record
- Weight chart used to record timed weighing of product in production.
- A sanitation log for each and every machine used in the reproduction of the product.
- A copy of the label master.
- All put together by the Quality Control Department.
Procedure for Manufacture
- All components are inventoried.
- Weighing and mixing is accomplished by two individuals signing each separate weighing and recording lot number of each component.
- Machinery and equipment used are cleaned, checked and sanitation logs completed.
- Weight checks are made following batch record at each phase of mixing, until completed.
- All documents and materials are checked and verified using in-process test records by the Quality Control Department before roceeding to the next manufacturing stage.
- Machinery is cleaned, checked, sanitation log completed and identified by name, product number, and quantity and lot number made.
- Granulation is placed into hopper of machine. Proper weight and hardness is achieved by tablet machine adjustment.
- During production, checks are recorded on weight chart at appropriate intervals.
- Tablets are disintegrated using official disintegration apparatus and time logged and checked. The disintegration processes exceed the U.S. Pharmacopoeia specification.
- At completion of compression part of the production the product is again sent back to Quality Control for verification of all parameters contained in the products in-process test records before moving on to the next manufacturing stage.
- The product which is then contained in suitable poly-lined identified container either goes to packaging staging area or to coating department.
- Coating pan is cleaned, checked and identified with appropriate sanitation log and filled with product.
- Coating is applied (film (protein) or enteric) and components names and lot numbers recorded on production card.
- Tablets are again disintegrated using official apparatus and using USP Disintegration Procedures described below.
- All data is then logged in disintegration log for future reference. Coated tablets are inspected, removed from pan and the product is again sent back to
- Quality Control for verification of all parameters contained in the products in-process test records before moving on to the next manufacturing stage.
- Product is then taken to packaging staging holding area.
- A copy of label master control sheet is made and identified with lot number and quantity of product.
- A control check sheet is also made out and accompanies the accumulated paper work.
- Labels checked against label master are issued and taken to packaging.
- All packaging machinery is cleaned, identified with product plaquard before use.
- Check list includes:
- Product name
- Product number
- Lot number
- Label check
- Code check
- Name of person that performed that specific stage of packaging.
- Content number in bottles is checked at appropriate intervals.
- Completed packaging is again sent back to Quality Control for verification of all parameters contained in the products in-process finished product test records before moving on to the next manufacturing stage.
- All products are inner sealed with safety seal and outer sealed with safety film seal, placed into trays and shrink wrapped.
- Child-resistant caps are used where required.
All record keeping for all phases of identification, formulation, raw material, packaging components, labels, finished products, shipping, order entry and quality control are maintained and backed up to 2 offsite centers as well as our own in-house backup system.
Disintegration of unit dose forms namely, "Tablets," is performed on all products at Nutri-West. A U.S.P. (United States Pharmacopoeia) testing apparatus is employed to determine the length of time required for a tablet to totally lose its physical form. This can be either minuscule pieces or powder or a completely saturated, soft, wet mass in the case of gelatinous types of formulae. The liquid testing media is official deionized (D.I.) water maintained at 37 degrees centigrade (body temperature). This is used for all tablets tested. Enteric coated tablets require the utilization of a simulated gastric solution and a simulated intestinal solution also maintained at 37 degrees centigrade. The apparatus consists of a thermostatically controlled water bath into which 1000 cc glass beakers filled with D.I. water are placed. Standing at the side of this water bath is a U.S.P. standardized gear box designed to raise and lower itself in a vertical axis at a rate of between 29 and 32 cycles per minute, through a distance of not less than 5.3 cm and not more than 5.7 cm. The top of this apparatus has a horizontal attachment onto which are hooked basket rack assemblies. The basket rack assembly consists of six open-ended glass tubes, each 7.75 by 0.25 cm long and having an inside diameter of approximately 21.5 mm and a wall approximately 2mm thick; the tubes are held in a vertical position by two plastic plates, each about 9 cm in diameter and 6 mm in thickness, with six holes, each about 24 mm in diameter, equidistant from the center of the plate and equally spaced from one another. Attached to the under surface of the lower plate is 10-mesh no. 23 (0.025 inch) W. and M. gauge woven stainless-steel wire cloth having a plain square weave. The parts of the apparatus are assembled and rigidly held by means of three bolts passing through the two plastic plates. There is currently a marketing exploitation being demonstrated by certain companies as a subversive effort to sell their calcium products. This is done by placing the tablet in water and/or vinegar to demonstrate visually the speed in which it breaks down. This is marketing "showman-ship," and has nothing to do with disintegration as it is done by scientific, U.S.P. guidelines. Any product can be manufactured with the use of additional excipients, such as AC-DI-SOL, which will allow it to disintegrate much more rapidly in any solution. However this means the addition of another excipient which we at Nutri-West keep at a minimum and still allow for maximum breakdown under U.S.P. regulation. At Nutri-West, a sample of each and every lot number is disintegrated and a permanent log is kept. If a product does not disintegrate under U.S.P. guidelines, it is discarded.
An excipient is an inert substance added to a tablet or capsule to give it the desired consistency, form, color and/or flavor. Because of manufacturing limitations, many of the lower potency vitamin/mineral formulations have more excipients than they do active ingredients. Significant numbers of people have hidden allergies or sensitivities to common food factors, such as lactose, gluten, yeast, corn, sugar or soy—all of which are often used as excipients in various tablets. This may be why some people will react to one brand of, say, B-complex vitamins and favorably to others with the same list of active ingredients. The fillers could make the difference. Sensitive people can actually undermine their health by prolonged use of products which aggravate their allergies. That’s too bad, because their intention is to take food supplements to maintain or improve health. Binders are used to hold all ingredients in the tablet together and to prevent shattering or breaking when it is compressed and released from the die. Examples are cellulose (plant fiber), gelatin, gum acacia, guar gum, vegetable stearine (a natural fat), lactose (milk sugar), and zein (corn protein). Glidants are used when needed to enhance the flow characteristics of certain powders which are not otherwise free flowing in the tableting machinery. Examples are silica, silicon dioxide, newer raw materials from rice proteins, etc. Lubricants are used to reduce friction by providing a smooth film to prevent tablets from sticking to the machinery. Examples are magnesium stearate, silica, magnesium oxide, stearic acid (a natural fat), and vegetable stearine. Fillers are used to fill out a tablet or capsule to a size and shape that conforms to the processing dies and is convenient for easy consumption. They also keep active ingredients from interacting with each other. They can be used in very tiny amounts (i.e. in high potency complex formulations) or in substantial amounts (i.e. in low potency or single ingredient tablets). Examples of fillers are dicalcium phosphate, casein (milk protein), lecithin, magnesium oxide, mannitol, wheat germ oil, soy oil, protein hydrosylate, sorbitol, tri-calcium phosphate, whey, lactose, calcium carbonate, calcium sulphate, wheat germ, gelatin, yeast, fructose, dextrose (glucose), dextrin, soy flour, bran flour, soy protein isolate, dolomite and cellulose. Disintegrants enable the tablet to be broken down in the digestive tract for effective utilization by the body. The active ingredients must be released from the tablet matrix as efficiently as possible. Examples are alginic acid, cellulose, citric acid, microcrystalline cellulose, sucrose (table sugar), lactose, vegetable gum, cornstarch and cellulose. Flavorings enhance the flavor of the tablets to make them more palatable. Examples are natural orange, natural vanilla, peppermint oil, fructose, sucrose, lactose, whey, sorbitol and mannitol. Coatings are used as an outside barrier to protect against moisture and potency loss, to control disintegration, to enhance appearance and to make the products easier to swallow. Perhaps the worst are the sugary, artificially colored coatings widely used by the pharmaceutical companies when they diversify into manufacturing vitamins. Other examples of coatings are cellulose, oleic acid, polyethylene glycol, food glaze (food shellac), and wax.
WHICH EXCIPIENTS ARE BEST?
The preceding section lists all manner of excipients--good, bad and indifferent. One of the poorest deserves mention. That is lactose, or milk sugar--a substance to which a majority of the world’s population are intolerant. For them it can cause diarrhea, constipation, fatigue and a whole range of related general and gastrointestinal complaints. At the time of writing, every prescription drug tablet manufactured in Canada contains lactose. Pharmaceutical companies obviously tend to use the same tableting process and the same excipients in their vitamin lines. From the preceding lists, perhaps the most innocuous excipients are cellulose, stearic acid, magnesium stearate, silica, di-calcium phosphate and sorbitol. These few substances can be used with some degree of interchange-ability as binders, fillers, glidants, lubricants and disintegrants. The most promising method of coating tablets is a process known as “aqueous film coating.” This is a recent development in the U.S. which has not yet found its way into Canada, possibly because the technology is too expensive to use for small production runs. Fill coating causes only a small increase in tablet weight, usually from 2 to 3%, thus keeping total excipients to a minimum. The use of water as a medium eliminates the need for harsh chemical solvents. Methyl cellulose is the most common aqueous film coating used. Every reputable manufacturer or distributor of food supplements in tablet form should be able to assure consumers that his products contain no sugar, no starch, no artificial colorings, no artificial flavorings, and no preservatives. Also, it is most advisable to turn out products which are hypoallergenic--i.e. which do not contain milk, wheat, corn, fish, treenuts, yeast or soy. If you have any questions, call or write to the manufacturer or distributor.
The honest ones will be glad to give you full details. There is one point worth emphasizing. High potency, broad spectrum formulations are very effective because they support so many nutritional processes. One can achieve a better result by using fewer of these tablets than by trying to combine fragmented products. Fewer tablets also mean fewer excipients in total. Also, each high potency tablet is so full of active ingredients that there is little room left for fillers, hence fewer excipients per tablet as well.
Chelation is the process by which the body absorbs minerals. During the digestion of meals, protein is broken down into amino acids, some of which surround (chelate) mineral ions, enabling them to be absorbed. This process is necessary because mineral ions have a positive electrical charge and the intestinal wall is negatively charged. Without the neutral charge of the surrounding amino acids, the minerals stick to the gut wall and are not absorbed. The whole process requires adequate hydrochloric acid and pepsin to break down protein into amino acids. Some manufacturers produce tablets in which supplementary minerals are pre-chelated with amino acids. These chelated minerals are better absorbed by those who have digestive weaknesses. Unfortunately, relying on them tends to bypass the real problem. It makes more sense to support the underlying digestive inadequacy with supplementary hydrochloric acid (HCl) and digestive enzymes. In that way the body will be able to absorb minerals from meals and not just from tablets. Non-chelated mineral supplements are well absorbed if taken with (a) meals and (b) supplementary enzymes and (c) hydrochloric acid (HCl), if needed.
Natural vs Synthetic
Much of the controversy over “natural” vs. “synthetic” stems from semantic confusion. “Natural” means “existing in or produced by nature.” “Synthetic” means “manufactured or man-made.” In a certain sense, no tablets are natural. They do not, for example, grow on trees. Supplements are man-made. To further complicate matters, the human body does a lot of synthesizing itself. It converts the amino acid, tryptophan, into the B-vitamin, niacinamide for example. All animals and all plants take certain raw materials and convert or synthesize them into other essential substances. Synthesis can itself be an entirely natural process. Man cannot manufacture vitamin C (ascorbic acid) in his liver the way that most other animals can. The vitamin C that is produced commercially is made from glucose outside the body in exactly the same way that animals make it from glucose inside the body. Is the end result natural or synthetic? Clearly it is both. The resulting ascorbic acid molecule manufactured commercially is identical to the one animals produce naturally. All and any scientific research uses ascorbic acid. Certain words are emotionally charged. The work “chemical,” for example, conveys to some people images of pollutants, contaminants and carcinogens. Yet, everything we eat or drink including water—is a chemical. Natural chemicals are those which our bodies need. Artificial chemicals are those which are foreign to our bodies. Synthetic chemicals are those produced in a laboratory—and may be either natural or artificial. Natural sources of vitamins are both unreliable and of low yield for manufacturing supplements. Brewer’s yeast is the richest natural source of B-vitamins, yet a whole tablespoonful contains, on average, only about 1.25 mg of thiamine (B-1), .34 mg of riboflavin (B-2), and 3 mg of niacin (B-3). This content fluctuates widely from batch to batch, making it difficult to maintain consistent label claims. Also, many people have sensitivities to yeast and might do better not to consume products from this source. In order to comply with the strict rules regarding the potency of vitamin products, manufacturers use crystalline vitamins. A crystalline vitamin is one which may be isolated in its pure form. Even the so-called “lowpotency” formulations use crystalline vitamins to meet government standards. All manufacturers of vitamin and mineral formulations—even those who claim to have all “natural” ingredients buy their raw materials from the same suppliers. There are very few original sources of ingredients. There are, for example, very few, if any producers of vitamin C in all North America. Labeling can be deceiving. “Rose Hips” vitamin and tablets, for example, often reveal a content of less than 5% rose hips powder—the balance being pure ascorbic acid. Who is kidding whom? Rose hips contain only a small percentage of ascorbic acid, and from 45 to 90% of that may be lost during the drying process. To provide, 1,000 mg of vitamin C entirely from rose hips, the tablet would have to be the size of a baseball and would cost hundreds of dollars (or perhaps thousands) per bottle. Entirely natural sources are both too expensive and too unreliable for the high potency which the body needs. Acerola cherries are the richest known natural source of vitamin C, yet they contain only about 1.6% of vitamin C by weight. Those manufacturers who claim to use only vitamin C from acerola are not telling the truth. They use the same manufactured vitamin C that everyone else does—with only a dash of acerola powder added. As long as we are talking about vitamin C and B-Complex vitamins, it does not matter where the vitamin comes from; the molecule is identical and is handled by the body in the same way. In other words, vitamin C from rose hips and vitamin C from cornstarch are identical in their pure form. There is a difference, however, in the structures of fat-soluble vitamins, A, D, and E. The various forms are physically different when viewed under a microscope and they are handled differently by the body. All reported cases of toxicity from vitamins A and D have been from the man-made, water-dispersible forms and not from the extracted kinds from fish liver oil. Synthetic vitamin E has not been proven toxic; however, it does not seem to be utilized as efficiently as the natural form. It thus takes more to get the same result. (“d-alphatocopherol” or E-succinate) is the natural form of vitamin E; “dl-alphatocopherol” is the synthetic. Again, many confuse “synthetic” with “artificial.” “Artificial” means “not found in nature.” A substance can be both natural and synthetic, if the final, man-made product is identical to its counterpart found in nature—as in the case of ascorbic acid and the B-vitamins. On the other hand, synthetic products can be artificial, as in the case of man-made vitamins A, D and E. The most artificial ingredients of all, of course, are the man-made colors, flavors and preservatives—none of which occur anywhere except in laboratories. What is important is not the hysterical claim of “all natural,” but how the substance performs in the body. Iron is a case in point. The pharmaceutical type of vitamin/mineral products usually contain iron in the form of ferrous sulfate, which is poorly assimilated and which can cause constipation.
Ferrous fumarate, iron peptonate and ferrous gluconate, on the other hand, are readily assimilated and do not cause constipation. The most effective formulations are those which provide as many nutrients as possible, in a reasonable balance. To improve results, the better combinations include extra synergistic factors. In a multi-vitamin/mineral formulation these extras could include certain herbs, amino acids, glandular concentrates, lipotrophic factors, bioflavonoids, betaine HCL, and/or RNA depending on the nature and purpose of the formula. The ultimate test of a supplement is, of course, does it get results? Does it do what it was meant to do?