Quality Control of Herbal Cosmetics: Quality control is a term that referred to processes involved in maintaining the quality and validity of the manufactured product. In herbal cosmetics, it includes microscopic evaluation, determination of ash, heavy metals, foreign matter and also includes micro-bacterial contamination. An important step in the evaluation of herbal products is the extraction of phytoconstituents. The choice of the extracting solvent depends on the nature of the compounds involved and might be deduced from the traditional uses. A special form of the assay is the determination of essential oils by steam distillation. When the active constituents (e.g. sennosides in Senna) or markers (e.g. alkylamines in Echinacea) are known, a vast array of modern chemical analytical methods such as ultraviolet/visible spectroscopy (UV/VIS), TLC, HPLC, GC, mass spectrometry (MS), or a combination of GC and MS (GC/MS), can be employed. Several problems not applicable to synthetic drugs influence the quality of herbal cosmetics:
- Herbal cosmetics are usually mixtures of many constituents.
- The active principle(s) is (are), in most cases unknown.
- Selective analytical methods or reference compounds may not be available commercially.
- Plant materials are chemically and naturally variable.
- Chemo varieties and chemo cultivars exist.
- The sources and quality of the raw material are variable.
The methods of harvesting, drying, storage, transportation, and processing (e.g. mode of extraction and polarity of the extracting solvent, instability of constituents, etc.) affect the quality of the product. Strict guidelines have to be followed for the successful production of quality herbal cosmetics. Among them are proper botanical identification, phytochemical screening, and standardization. Quality control and the standardization of herbal cosmetics involve several steps. The source and quality of raw materials, good agricultural practices, and manufacturing processes are certainly essential steps for the Quality control of herbal cosmetics and play a pivotal role in guaranteeing the quality and stability of herbal preparations. The quality of a plant product is determined by the prevailing conditions during growth, and accepted Good Agricultural Practices (GAP) can control this. These include seed selection, growth conditions, and use of fertilizers, harvesting, drying, and storage. GAP procedures are and will be, an integral part of quality control. Factors such as the use of fresh plants, age and part of the plant collected, period, time and method of collection, the temperature of processing, exposure to light, availability of water, nutrients, drying, packing, transportation of raw material, and storage, can greatly affect the quality, and hence the therapeutic value of herbal cosmetics.
Apart from these criteria, factors such as the method of extraction, contamination with micro-organisms, heavy metals, and pesticides can alter the quality, safety, and efficacy of herbal drugs. Using cultivated plants under controlled conditions instead of those collected from the wild can minimize most of these factors. Sometimes the active principles are destroyed by enzymes processes that continue for long periods from collection to marketing, resulting in a variety of compositions. Thus proper standardization and quality control of both the raw material and the herbal preparations should be conducted.
Standardization of Herbal Cosmetic Products
Standardization involves adjusting the herbal drug preparation to a defined content of a constituent, or a group of substances with known therapeutic activity by adding excipients or by mixing herbal drugs or herbal drug preparations. Botanical extracts made directly from crude plant material show substantial variation in composition, quality, and therapeutic effects. Standardized extracts are high-quality extracts containing consistent levels of specified compounds, and they are subjected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes. No regulatory definition exists for the standardization of dietary supplements. As a result, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality.
When the active principles are unknown, marker substance(s) should be established for analytical purposes and standardization. Marker substances are chemically defined constituents of an herbal that are important for the quality of the finished product. Ideally, the chemical markers chosen would also be the compounds that are responsible for the botanical’s effects on the body. There are two types of standardization:
(A) In the first category, “true” standardization, a definite phytochemical or group of constituents is known to have activity. Ginkgo with its 26% ginkgo flavones and 6% terpenes is a classic example. These products are highly concentrated and no longer represent the whole herb, and are now considered as phytocosmeceuticals. In many cases, they are vastly more effective than the whole herb. However, the process may result in the loss of efficacy, and the potential for adverse effects and herb-drug interactions may increase.
(B) The other type of standardization is based on manufacturers guaranteeing the presence of a certain percentage of marker compounds; these are not indicators of the therapeutic activity or quality of the herb. In the case of herbal cosmetic preparations, the production and primary processing of the medicinal plant or herbal drug has a direct influence on the quality of the active pharmaceutical ingredients (APIs) due to the inherent complexity of naturally growing medicinal plants and the limited availability of simple analytical techniques.
To identify and characterize the active constituents solely by chemical or biological means, there is a need for an adequate quality assurance system. This assurance is also required during cultivation, harvesting, primary processing, handling, storage, packaging, and distribution. Deterioration and contamination through adulteration, especially microbial contamination, can occur at any one of these stages. It is extremely important to establish good agricultural, harvesting, and manufacturing practices for herbal starting materials to minimize the undesirable factors. In this regard producers, processors, and traders of medicinal plants or herbal cosmetics have an obligation and a role to play. The manufacturers and suppliers of herbal products should adhere to quality control standards and good manufacturing practices by carrying out remarket reviews of all drugs before they are authorized for sale. The products available in the market are analyzed regularly to ensure that they are free of unsafe ingredients and that the products contain the ingredients indicated on the labels.
Market Analysis of Herbal Cosmetics
There are several major steps in herbal cosmetic products manufacturing starting from herbal crop planting to herbal product manufacturing and marketing. Chemical engineers are involved once the herb is harvested where quick preprocessing and correct storage is required. Preprocessing involves reducing the size of the herb through chopping and grinding to prepare for processing, while a good storage method ensures that the active phytochemicals are maintained before processing.
Processing is a critical aspect of herbal cosmetic production, especially due to the low yield of extracts. Processing methods are usually based on traditional methods such as high-pressure water extraction for herbs which are traditionally boiled as decoctions. New innovative methods such as Supercritical Fluid Extraction (SFE) where supercritical fluids such as carbon dioxide under high pressure are utilized to produce herbal extracts needed to be developed to produce herbal products of higher yield, lower operating costs, and faster production times. Packaging and sale follow processing.
Good Manufacturing Practice (GMP) is a code of practice used by the medical and health-related industries including the pharmaceutical industry to maintain the highest standards of quality in the development, manufacture, and control of medicinal products. In Malaysia, the GMP certification is issued by the National Pharmaceutical Control Bureau (NPCB), which is issued as an annual Manufacturing License to which it can be revoked at any time if the facilities are found not to meet the standards of GMP. Herbal cosmetic products can only be sold by manufacturers who utilize GMP as it ensures that the herbal product safety and pure. In addition, manufacturers intending to export their products must ensure that their target markets accept their GMP practices. A key issue in manufacturing herbal products and medicines is standardization. Standardization is the process of producing herbal extracts or phytochemicals in which product potency is guaranteed through consistency in active compound content level. This process requires high knowledge in phytochemical analysis and process technology to ensure the quality assurance required. The increase of value in herbal products as increased processing and standardization is carried out.
In addition, as the overall phytochemical yield of herbal extracts is between 2-5%, it is important to develop expertise in optimizing the process as process profitability can be increased through:
- Reduction of utility usage.
- Increase in phytochemical yield.
- Reduction of extraction solvents.
- Reduction of processing time.
There are almost no data available on the physical and chemical properties of the phytochemical or herbal medium to be processed, hence, process design and optimization is currently a trial and error procedure. There is also a strong need to build up scale-up knowledge, either through a theoretical basis or pilot plant experiments, as frequently only laboratory data is available. Among key problems that must be addressed, including developing process design knowledge for herbal extraction. Currently, much herbal extraction design is done based on knowledge from food technologists. Often these design methods do not take into account chemical thermodynamic data or design methods. Process models built are not easily replicated or utilized as many are based on surface response methodologies which are only applicable to the equipment investigated. More first principle modeling methods need to be developed to model, optimize, and scale-up herbal extraction processes.
Pharma and cosmetics market in India is valued at about ` 35000 crores, and growing at 10% per year. Carving out a niche of ` 50 crores in this market is fairly easy if the products chosen can catch the fancy of the consumer. Different marketing strategies are used for the products. Brand building and direct selling are the most widely used. Brand building is very expensive. Direct selling in a well-defined geographic area is a low-cost option but the gestation period is high. It will be prudent to take up contract manufacturing work for 50% capacity and introduce your products in a phased manner.
Cosmeceuticals represent the fastest-growing segment in the skin-care market, and several topical cosmeceuticals treatments for conditions such as photoaging, hyperpigmentation, and wrinkles have come into widespread use. In 2015, the U.S. cosmeceuticals market was estimated to be $12.5 billion and projected to grow to over $16 billion by 2020.
After China, India is the most bio-diverse country. Despite the global economic downturn, India remains one of the fastest-growing beauty markets globally, growing at 13 percent per annum and valued at $6.3 billion. The global organic cosmetics industry is valued at $7 billion. The market offers extensive opportunities for domestic and international players. Despite the recession period, all these companies have seen an 18 percent growth this year.
The EU market is estimated at approximately $1.1 billion, and manufacturers continue developing UV absorbers with broad-spectrum protection. Given that almost all cosmeceutical formulations are focused on the skin and hair care segment of the market (perhaps 15 percent of the former and five percent of the latter), we can safely estimate the EU market for cosmeceuticals at approximately $1.5 – $1.75 billion.
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