Botanical drug extract

All chapters, especially the last two, contain information that has not been published previously. The chapter on solid-liquid extraction technologies, for example, presents and discusses both theoretical and practical aspects of these technologies, from fundamental concepts of equilibrium and mass transfer to equipment selection and design. Similarly, the chapter on safety of botanicals reviews safety issues of botanicals associated with misidentification of plant species, misuse of products, product adulteration and botanical/drug interactions. 

The general method of preparation (e.g., pulverization, decoction, expression, aqueous extraction, or ethanolic extraction) is provided under 312. 23(a)(7)(iv)(a). This is especially important where more than one process exists in the literature onwhich the safety of the botanical drug substance is based. 

Among the various prerequisites for a perfect quality proof of these herbal drugs, authentication and safety proof take first precedence. Identification was in former times primarily synonymous with the macroscopic and microscopic botanical authenticity. Since that time, however, chemical composition and particularly the complex entities of the low molecular constituents have become of greater interest for oral medicinal application and thus in evaluating the pharmacological effects and therapeutic efficacy of the plant drug extracts obtained by decoction or other extraction processes. 

Is the BCS that was developed with reference to chemically characterized and well-defined synthetic drug substances relevant for application and or adoption to botanical preparations (8) If one assumes, as is reasonable, that bioavailability of the active component(s) in a botanical dosage form depends on both solubility and permeability, the solubility of the botanical extract could be controlled through appropriate formulation technology and dissolution testing. The applicability of the BCS to botanical preparations will certainly be increasingly researched, debated, and discussed in the coming years. 

In the early days, until the late 1800s, most drugs were based on herbs or extraction of ingredients from botanical sources. 

In theory, all impurities should be eliminated. In practice, it is generally not economically feasible to totally eliminate all impurities. However, the levels of all impurities should be controlled to provide a consistent product. In most cases, only low levels of impurities should be allowed, but in rare cases, even quite high levels of impurities are tolerated. In some cases, for example, biotechnology derived products such as macrocyclic antibiotics, or extracts of a botanical source such as some dietary supplements, the drug substance or active component contains multiple compounds, all of which have biological activity. However, only organic impurities, which include residual solvents in the drug substance, are addressed in this chapter. 

Although it may not always be possible to control the sources or extraction conditions to produce only a single component, they should be arranged so as to produce, as far as possible, a consistent mixture. Impurity profiles of botanical products are often monitored by a number of anal3hical procedures to ensure product quality. Minor components that have pharmacological activity should not necessarily be viewed as impurities. In some cases, the activity of a botanical or fermentation drug substance may be attributed to a number of components. 

Dietary supplements are products taken by mouth that contain an ingredient intended to supplement the diet, such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including extracts, concentrates, tablets, capsules, gel caps, liquids, and powders. They have special requirements for labeling. In the U.S., the Dietary Supplement Health and Education Act of 1994 states that dietary supplements are considered foods, not drugs. (Note that some dietary supplements are used in conventional medicine for example, folic acid... 

Based on the same principle of modulation of drug absorption, other less known botanicals could produce similar or different effects compared to St. John s wort. Rosemary (Rosemarinus officinalis Labiatae) is a commonly used dietary botanical that has been found to have a chemopreventive effect (24). Furthermore, in drug-resistant MCF-7 human breast cancer cells expressing P-glycoprotein, methanol extracts of Rosemary at two concentrations (16.5 and 85 pg/mL) inhibited the efflux and increased intracellular accumulation of doxorubicin and vinblastine, two chemotherapeutic drugs that are known substrates of P-glycoprotein. Treatment of drug-resistant cells with the extracts also increased the cytotoxic effects of doxorubicin. On the other hand, in wild-type MCF-7 cells that do not express... 

As with drugs and purified biomarkers, thermal- and photostability of botanical products are the factors that must be considered. Commercial dried extract and capsules of SJW were evaluated under harmonized test conditions (25). Photostability testing showed all the constituents to be photosensitive in the tested conditions. However, different opacity agents and pigments influenced the stability of the constituents. Amber containers had little effect on the photostability of the investigated constituents. Long-term thermal stability testing showed a shelf life of less than four months for hyperforins and hypericins, even when ascorbic and citric acids were added to the formulation. 

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