Chinese New Year, also known as Spring Festival or the Lunar New Year,
is the festival that celebrates the beginning of a new year on the traditional Chinese calendar.
Hope everything will goes well with everybody in this new year!
They can be divided in to desired dosage strength without process or formulation changes.
When pellets containing the active ingredient are in the form of suspension, capsules, or disintegrating tablets, they offer significant therapeutic advantages over single unit dosage forms.
They can also be blended to deliver incompatible bioactive agents.
They can also be used to provide different release profile at the same or different sites in the gastrointestinal tract.
Pellets offer high degree of flexibility in the design and development of oral dosage form like suspension,sachet, tablet and capsule.
Pellets disperse freely in gastro intestinal tract (GIT), maximize drug absorption, and minimize local irritation of the mucosa by certain irritant drugs.
Improved flow characteristics: Spheres have excellent flow properties, which can be used in automated processes or in processes where exact dosing is required, e.g. tableting, moulding operations, capsule filling, and packaging.
Coating: Coating of granules is often applied for stabilizing active ingredients in the granule or to control the release of these active ingredients. Typical applications in the pharmaceutical industry are the controlled release medicines. The easiest shape to coat is the sphere due to the absence of edges. It is also the most economical one to coat as no extra coating material is required to fill irregularities in the surface of the granules.
Packing of beds and columns: In certain processes, porous beds or columns are used as chemical reactors. Spherical particles allow the reproduction of beds withalways the same void volume, surface area and permeability. Calculations and predictions of the process characteristics also become easier when round particles are used as many equations are based on flows around symmetrical bodies.
Density increase: Both the true and the bulk density of granules are increased by spheronising. This can improve the process and the packaging.
Marketing: For consumer products, spheronising is sometimes only applied for improved product appearance and marketing reasons.
Hardness and friability: Hardness and friability depend on the internal cohesive forces and surface characteristics. Spheronization increases the hardness and reduces the friability of granules. This will reduce the amount of fines generated during handling or transportation.
With the rapid development of China's health food industry, the management of its raw materials and products needs to be continuously improved to meet the growing needs of the people for a better life. The United States has the largest health food market in the world, which provides material for health food researchers and regulation-making departments in China to draw on. So, let's take a look at the industrial economy and related laws regarding Dietary Supplement in the United States. Here are some answers.
Here is the content list:
l The Dietary Supplement industry is an important part of the US economy.
l Laws relating to the Dietary Supplement in the US.
The Dietary Supplement industry is an integral part of the US economy and the industry has always been committed to a positive trade balance. It is estimated that 600 Dietary Supplement manufacturers in the United States produce approximately 4,000 products, with annual sales of at least $4 billion for these products alone. To promote health, the US government has taken legislative action to protect consumers' rights to safe Dietary Supplements and to establish a rational federal framework to replace the ad hoc patchwork of Hard capsules regulatory policies, thus amending the Federal Food, Drug, and Cosmetic Act and creating the Dietary Supplement Health and Education Act (DSHEA). The DSHEA was an important milestone in the regulation of the Dietary Supplement in the US.
In addition to the FD&C Act and DSHEA, the Nutrition Facts Labeling and Education Act of 1990, an amendment to the FD&C Act, requires that most foods must have a nutrition facts label and that the food label posted must contain a statement of nutrient content, as well as some health information to meet specific requirements. The Dietary Supplement Good Manufacturing, Packaging, Labelling and Storage Practices (CGMP), issued in 2007, covers the requirements for personnel, premises, equipment and facilities, production and process control systems (quality control, package labeling, manufacturing records, batch production records, laboratory operations, manufacturing operations, packaging and labeling operations), storage and transport, repatriation of the Immunity increases, product complaints, records, and documentation. The Food Safety Modernization Act (FSMA) of 2011 amended the FD&C Act concerning the safety aspects of the food supply, with an emphasis on improving prevention, monitoring, and response to food safety issues. The Food Safety Modernisation Act 2011 (FSMA) amends the FD&C Act regarding the safety aspects of the food supply, to improve the prevention, monitoring, and response to food safety issues so that the industry and consumers can better understand and implement the Act. Draft Guidance Document New Dietary Supplement Declarations and Related Issues, food Labelling Guidelines.
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Sulfur is essential, but for humans, it is not recommended for intake. Instead, recommended intakes have been established for the sulfur-containing amino acids methionine and cysteine. There are Dietary Supplements that provide sulfur, such as taurine. Next, let's take a look at the types of Dietary Supplements available. Here are some answers.
Here is the content list:
l Protein and amino acids
Although, in general, Dietary Supplements are not allowed to be labeled and marketed with claims of disease prevention or treatment, the US Food and Drug Administration (FDA) has conducted a scientific review of certain foods and Dietary Supplements. They concluded that there is a significant scientific consensus and specifically published permissible health words. An initial ruling allowing health claims for calcium Dietary Supplements and osteoporosis was later amended to include calcium supplements with or without vitamin D, effective January 1, 2010. Examples of the permitted wording are shown below. To meet the health requirement for calcium, Health care must contain at least 20% of the reference dietary intake, which for calcium means at least 260 mg/serving.
In the same year, the European Food Safety Authority approved Dietary Supplement's health claims for calcium and vitamin D, which can reduce the risk of osteoporotic fractures by reducing bone loss. The US FDA has also approved Qualified Health Claims (QHC) for calcium, selenium, and chromium picolinate for various health conditions, which have scientific evidence but do not meet the more stringent "significant scientific agreement" criteria required for authorized health claims. If Hard capsules choose to make such a claim, the FDA specifies the exact wording of the QHC to be used in labeling and marketing materials. The wording could be cumbersome: "One study suggests that selenium intake may reduce the risk of bladder cancer in women. However, another smaller study showed that the risk was not reduced. Based on these studies, the FDA concludes whether selenium supplements may reduce the risk of bladder cancer in women."
Whey protein is a popular ingredient, but products may also contain casein, soy, pea, and rice proteins. The same protein ingredients as those commercially available in Immune Supports can be incorporated into meal replacements and medical foods, but they are administered and labeled differently from supplements. In the US, "meal replacement" products are food products and are labeled accordingly. These usually contain protein, carbohydrates, fats, vitamins, and minerals. There may be claims such as "good source of protein", "low fat" or "lactose-free". It also designed to be a nutritionally complete medical food that is used under the care of a doctor or other licensed healthcare professional.
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Dietary Supplement products have a crucial impact on our lives, especially in the medical and food industries. Since Dietary Supplement is so important, let's take a look at the differences between Chinese and foreign Hard capsules products and their outlook. Here are some answers.
Here is the content list:
l The differences between Chinese and foreign Dietary Supplements.
l Prospective analysis of Dietary Supplement.
Firstly, Dietary Supplement has not yet become a legal definition in China, whereas it is a legal concept in the USA. Secondly, Dietary Supplement in China is a product set that straddles health food and general food, while Dietary Supplement in the United States is the third category of product that is different from general food and medicine. Thirdly, the ingredients of Dietary Supplement in China must be essential nutrients or biologically active substances with relatively clear constitutive relationships, whereas Dietary Supplement in the US does not have such a definition. Fourthly, the purpose of the Dietary Supplement in China is to improve the health of the body and reduce the risk of disease, whereas the purpose of Dietary Supplement in the USA is to supplement dietary ingredients. Fifthly, Health food in China has the status of healthy food and therefore can claim to assist in lowering blood lipids and eliminating melasma, while Dietary Supplements in the US cannot make such claims.
The most important uncertainties in the hazard characterization of Dietary Supplement presented by the US National Research Council arise from the following issues: firstly, if animal information is used, which toxicity endpoints should be considered, and which indicators of representation should be used. Secondly, what are the differences in bioavailability and dose-response relationships between animals and humans? Thirdly, if human information is used, what are the damaging effects of use, and what are the differences between dose-response relationships. Fourth, how information on subchronic exposures can be used to estimate the risk of lifetime exposure. Fifth, how information on non-dietary route exposures is used.
The information used to determine human effect levels for the Dietary Supplement is inadequate and we should focus on using appropriate techniques to better identify and quantify these parameters, such as the use of appropriate and sensitive exposure/effect biomarkers. In addition, ULs for most nutrients are formulated in terms of body weight, whereas RDAs can be expressed in terms of energy intake or unsaturated lipid intake, which raises the question of which indicator to use. The toxic effects of nutrient requirements and excesses vary according to the life cycle, for example during pregnancy.
Information on nutrient interactions and the different exposure settings of individuals has led to the recognition that for some Dietary Supplements a single NOAEL cannot be used alone and that further understanding of population differences in nutrient interactions may be useful in conducting risk assessments and determining appropriate ULs.
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Health food is a supplement based on vitamins, minerals, and extracts with a relatively clear structure-activity relationship, which is taken orally to supplement essential nutrients and bioactive substances to improve health and reduce the risk of disease. The following Dietary Supplement manufacturers will introduce you to the characteristics and requirements of Dietary Supplements. Here are some answers.
Here is the content list:
l What are the characteristics of Dietary Supplements?
l What requirements must a Dietary Supplement meet?
The raw materials used in Dietary Supplement are mainly taken from natural species, but there are also safe and reliable substances produced through chemical or biological technology, such as plant and animal extracts, vitamins, minerals, amino acids, etc. Generally speaking, the physical and chemical properties of the functional ingredients are relatively stable, the chemical structure is relatively clear, the mechanism of action has been scientifically proven to a certain extent, and the safety, functionality, and quality control meet the regulatory standards.
Dietary Supplement is mainly available in the form of pharmaceutical-like products in the following dosage forms: hard capsules, soft capsules, tablets, oral liquids, granules, powders, etc. The packaging forms are pre-packaged in bottles, drums (boxes), bags, and aluminum blister packs.
Immunity increases with the status of general food can follow the requirements of the "Nutritional Labelling Regulation for Food" issued by the Ministry of Health in 2008 and label the product with nutrition or nutrient function claims. Health food products approved by the health administration can only claim the specific health functions approved, and the publication of advertisements needs to be approved by the State Drug Administration. Dietary Supplement, on the other hand, can only claim to supplement (specifically) nutrients.
Firstly, Dietary Supplement containing more than three (inclusive) vitamins and minerals can only be described as a complex or multiple Dietary Supplement. The label and instructions should indicate each content, recommended intake, method of storage and precautions, etc. Thirdly, Dietary Supplements should consist of one or more vitamins or minerals in the form of tablets, capsules, tablets, or oral liquid; the daily consumption of tablets should not exceed 20 grams and the daily consumption of oral liquid should not exceed 30 ml. Fourthly, Dietary Supplements must obtain a health food approval certificate before they can be manufactured and sold. Fifthly, the excipients added to Dietary Supplements should be mainly to enhance the product's process performance or improve the taste of the product. Sixth, the raw materials and excipients in Skin care should provide their sources and quality standards; chemically synthesized Dietary Supplement raw materials should be "Hygienic Standards for the Use of Food Additives", the relevant circulars of the Ministry of Health or the Pharmacopoeia of the types of Dietary Supplement raw materials allowed to be used and comply with the corresponding provisions, otherwise, Otherwise, it should be evaluated for safety and toxicology concerning the requirements for new food resources and provide scientific proof of safe human intake.
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There is no single product category for our health food products in the USA. Most health food products can be classified as Dietary Supplement or general food with functional claims, and all of them fall within the scope of food regulation. Next, let's take a look at the scope of a Dietary Supplement in the United States and the regulatory authorities. Here are some answers.
Here is the content list:
l The scope of Dietary Supplement in the USA.
l Regulatory authority for Dietary Supplement in the United States.
A Dietary Supplement is a product (not tobacco) intended to supplement the diet and may contain one or more of the following dietary ingredients: vitamins, minerals, herbs (herbal) or other plants, amino acids, and dietary ingredients to increase the total daily intake, or a concentrate, metabolite, extract or combination of these ingredients. It may not be consumed in the form of tablets, capsules, powders, soft gels, or oral liquids; it may not be consumed as a conventional food or as the sole component of a meal diet. DSHEA also allows the use of pharmaceutical ingredients, such as approved or licensed new drugs, antibiotics, biologics, etc., provided that they have been marketed as Immunity increases or food before the relevant approval, certification, or licensing; however, if they have not been marketed as a Dietary Supplement or food before the relevant approval or certification, they may not be used as a Dietary Supplement. However, if the substance has not been marketed as a Dietary Supplement or food before the relevant approval or certification, it may not be used in Dietary Supplement.
The US Food and Drug Administration (FDA), one of the federal executive agencies of the Department of Health and Human Services (HHS), is the regulatory authority for Dietary Supplement, which is different from "conventional" foods and drugs, primarily under DSHEA, which was established in 1994. Dietary Supplements and Dietary Ingredients Manufacturers and distributors of dietary supplements and dietary ingredients are responsible for assessing the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and the relevant FDA regulations. The Centre for Food Safety and Applied Nutrition (CFSAN) is responsible for the safety and labeling of the Hard capsules. The National Institutes of Health (NIH), one of the HHS divisions, focuses on scientific research and the NIH Office of Dietary Supplement (ODS) coordinates the overall management of the Dietary Supplement. The common goal of NIH and FDA is to promote public health by facilitating the translation of basic and clinical research into medical products and treatments. These agencies complement each other in their roles and functions: NIH supports and conducts biomedical and behavioral research, and FDA ensures the safety and efficacy of medical and other products. In addition, the Committee on Dietary Supplement Labelling (CDSL) examines the regulatory and Dietary Supplement claims on labels and provides recommendations on how best to provide consumers with information that is truthful, scientifically valid, and not misleading. The Commission is composed of seven members appointed by the President. The members of the committee should have expertise and experience in the manufacture, regulation, distribution, and use of Dietary Supplement. At least three of the members should have scientific training and experience to assess the health benefits of Dietary Supplement use, and one of the members should have experience in pharmacology, medical botany, traditional herbal medicine, or other science-related fields. Committee members and staff should be free from bias on Dietary Supplement issues.
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Omega-3 fatty acids are found in foods, such as fish and flaxseed, and in dietary supplements, such as fish oil.
The three main omega-3 fatty acids are alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). ALA is found mainly in plant oils such as flaxseed, soybean, and canola oils. DHA and EPA are found in fish and other seafood.
ALA is an essential fatty acid, meaning that your body can’t make it, so you must get it from the foods and beverages you consume. Your body can convert some ALA into EPA and then to DHA, but only in very small amounts. Therefore, getting EPA and DHA from foods (and dietary supplements if you take them) is the only practical way to increase levels of these omega-3 fatty acids in your body.
Omega-3s are important components ofthe membranes that surround each cell in your body. DHA levels are especially high in retina (eye), brain, and sperm cells.Omega-3s also provide calories to give your body energy and have many functions in your heart, blood vessels, lungs, immune system, and endocrine system (the network of hormone-producing glands).
How much omega-3s do I need?
Experts have not established recommended amounts for omega-3 fatty acids, except for ALA. Average daily recommended amounts for ALA are listed below in grams (g). The amount you need depends on your age and sex.