Excipient Health Dictionary

Excipient: From 3 Different Sources


A substance which is not an active part of a preparation, but is combined with active ingredients to achieve a suitable dose or for the purposes of colouring, preservation, etc. Usually believed to be inert and non-toxic. 
Health Source: Bartrams Encyclopedia of Herbal Medicine
Author: Health Encyclopedia
An inert substance added to a prescription in order to make the remedy as prescribed more suitable in bulk, consistence, or form for administration.
Health Source: Medical Dictionary
Author: Health Dictionary
n. a substance that is combined with a drug in order to render it suitable for administration; for example in the form of pills. Excipients should have no pharmacological action themselves.
Health Source: Oxford | Concise Colour Medical Dictionary
Author: Jonathan Law, Elizabeth Martin

Essential Oils

Volatile oils. Out of 250,000 flowering plants only 2,000 yield essential oils. Soluble in alcohol, colourless. Contained in plants, they are responsible for taste, aroma and medicinal action. Organic properties give the flower its scent. May be anti-bacterial, antispasmodic, sedative, expectorant, antiseptic, anti-inflammatory. The smell of a flower roughly conveys the potency of its oil. An example is menthol in the mint family.

Oils used in Phytotherapy: Almond, English Chamomile, Aniseed, Bergamot, Black Pepper, Buchu, Camphor, Cedarwood, Cloves, Coriander, Cypress, Eucalyptus, Geranium, Juniper, Lavender (French), Lavender (English), Lavender (Spanish), Lemon, Marjoram, Orange (sweet), Patchouli, Peppermint, Pine (Scots), Rosemary, Sage, Sandalwood, Thyme, Spearmint, St John’s Wort, Turpentine, Ylang Ylang.

Most oils are obtained by steam distillation. Being highly concentrated, internal use is by a few drops, diluted. About 30-40 are used medicinally; each having its own specific healing properties. Some are convenient as inhalants; a few drops on a tissue for relief of catarrh, colds, etc. Fragrant burners and electronic diffusers are available for vapour-inhalation. Bring to boil 2 pints water; allow to stand 3-4 minutes; sprinkle on the surface 5-10 drops Eucalyptus oil and with towel over head, inhale steam, 5-10 minutes.

Examples: (a) equal parts dilute oils of Thyme and Hypericum (acute middle ear inflammation) 3-4 drops injected into ear 2-3 times daily. (b) 10 drops oil Marjoram in bath water for cramp. Eucalyptus is a useful antibacterial; Cinnamon (anti-inflammatory), Juniper (urinary antiseptic), Orange blossom (anti- depressant), Lavender (sedative).

Essential oils should never be used neat, except as prescribed by a suitably qualified practitioner. While aromatherapists do not prescribe internally, Dr Paul Belaiche, one of France’s leading experts on essential oils, advises oral medication at a maximum daily dosage of 12 drops according to the oil. He advises drops on the tongue, on activated charcoal, in capsule form using a suitable excipient or vegetable oil, or mixed with a little honey. Anal injection has proved successful, (8-10 drops in 10ml vegetable oil) or suppositories made from 200-300mg (8-10 drops) essential oil to 2 grams of base per suppository. Oils should never be allowed to touch the eyes.

Capsules of Garlic oil may be inserted into the rectum for worms or prostate disorder. OR: 10 drops oil mixed with 10ml vegetable oil and injected with the aid of a pipette. Dilute oil of Thyme is used as a massage-rub for chest infections. Oil of Cloves is not only an antiseptic but an analgesic to assuage moderate dental pain. Volatile oils reflexly stimulate the medulla through the olfactory nerve, thus promoting appetite and flow of saliva. All stimulate production of white blood cells and thereby support the immune system.

Oils not used: Basil, Bitter Almonds, Boldo, Calamus, Horseradish, Mugwort, Mustard, Pennyroyal, Rue, Sassafras, Savin, Tansy, Thuja, Wormseed.

Oils not used in pregnancy: Bay, Buchu, Chamomile, Clary Sage, Cinnamon, Clove, Fennel, Hyssop, Juniper, Marjoram, Myrrh, Peppermint, Rose, Rosemary, Sage, Thyme. All other oils – half the normal amount.

Tea: 2-3 drops, selected oil, on teabag makes 3 cups tea.

Inhalant: 10 drops on tissue, or same amount in hot water to inhale steam.

Bath water: add: 10-15 drops.

Compress: 10-15 drops in half a cup (75ml) milk or water. Soak suitable material and apply.

Massage: 6 drops in two teaspoons ‘carrier’ vegetable oil (Almond, Peanut, Olive, etc).

Fragrant oils replace hospital smell.

Essential oil suppliers: Butterbur and Sage, 101 Highgrove Street, Reading RG1 5EJ. Also: Shirley Price Aromatherapy, Wesley House, Stockwell Road, Hinckley, Leics LE10 1RD. ... essential oils

Labelling Of Herbal Products

The law requires labels to carry a full description of all ingredients. No label should bear the name of a specific disease or promote treatment for any serious disease or condition requiring consultation with a registered medical practitioner. Labels must not contravene The Medicines (Labelling and Advertising to the Public), SI 41, Regulations, 1978.

Misleading claims and the use of such words as “organic”, “wholesome”, “natural” or “biological” cannot be accepted on product labels. The Licensing Authority treats herbal manufacturers no differently than manufacturers of allopathic products for serious conditions.

The Advertising Standards Authority does not allow quotation of any medicinal claims, except where a Product Licence (PL) has been authorised by the Licensing Authority.

All labels must include: Name of product (as on Product Licence), description of pharmaceutical form (tablet, mixture etc), Product Licence No., Batch No., quantity of each active ingredient in each unit dose in metric terms; dose and directions for use; quantity in container (in metric terms); “Keep out of reach of children” or similar warning; Name and address of Product Licence Holder; expiry date (if applicable); and any other special warnings. Also to appear: excipients, method/route of administration, special storage instructions, and precautions for disposal, if any.

Where licences are granted, the following words should appear on the label of a product: “A herbal product traditionally used for the symptomatic relief of . . .”. “If symptoms persist see your doctor.” “Not to be used in pregnancy” (where applicable). “If you think you have . . . consult a registered medical practitioner before taking this product.” “If you are already receiving medical treatment, tell your doctor that you are taking this product.” These warnings are especially necessary should symptoms persist and be the start of something more serious than a self-limiting condition.

Herbal preparations should be labelled with the additives and colourings they contain, if any. This helps practitioners avoid prescribing medicines containing them to certain patients on whom they may have an adverse reaction.

Labels of medicinal products shall comply with the Medicines (Labelling) Regulations 1976 (SI 1976 No. 1726) as amended by the Medicines (Labelling) Amendment Regulations 1977 (SI 1977 No. 996), the Medicines (Labelling) Amendment Regulations 1981 (SI 1981 No. 1791) and the Medicines (Labelling) Amendment Regulations 1985 (SI 1985 No. 1558).

Leaflets issued with proprietory medicinal products shall comply with the requirements of the Medicines (Leaflets) Regulations 1977 (SI 1977 No. 1055).

See also: ADVERTISING: CODE OF PRACTICE. BRITISH HERBAL MEDICINE ASSOCIATION. ... labelling of herbal products

Dextrin

n. a carbohydrate formed as an intermediate product in the digestion of starch by the enzyme amylase. Dextrin is used in the preparation of pharmaceutical products (as an *excipient) and surgical dressings.... dextrin

Herbal Medicine

“There is a large body of opinion to support the belief that a herb that has, without ill-effects, been used for centuries and capable of producing convincing results, is to be regarded as safe and effective.” (BHMA) Claims for efficacy are based on traditional use and inclusion in herbals and pharmacopoeias over many years. Their prescription may be prefixed by: “For symptomatic relief of . . .” or “An aid in the treatment of . . .”

To establish efficacy of treatment for a named specific disease by herbs, the DHSS requires scientific data presented to the Regulatory authorities for consideration and approval.

A product is not considered a herbal remedy if its active principle(s) have been isolated and concentrated, as in the case of digitalis from the Foxglove. (MAL 2. Guidance notes)

A herbal product is one in which all active ingredients are of herbal origin. Products that contain both herbal and non-vegetable substances are not considered herbal remedies: i.e. Yellow Dock combined with Potassium Iodide.

The British Government supports freedom of the individual to make an informed choice of the type of therapy he or she wishes to use and has affirmed its policy not to restrict the general availability of herbal remedies. Provided products are safe and are not promoted by exaggerated claims, the future of herbal products is not at risk. A doctor with knowledge and experience of herbal medicine may prescribe them if he considers that they are a necessary part of treatment for his patient.

Herbalism is aimed at gently activating the body’s defence mechanisms so as to enable it to heal itself. There is a strong emphasis on preventative treatment. In the main, herbal remedies are used to relieve symptoms of self-limiting conditions. They are usually regarded as safe, effective, well-tolerated and with no toxicity from normal use. Some herbal medicines are not advised for children under 12 years except as advised by a manufacturer on a label or under the supervision of a qualified practitioner.

World Health Organisation Guidelines

The assessment of Herbal Medicines are regarded as:–

Finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.

Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.

The past decade has seen a significant increase in the use of herbal medicines. As a result of WHO’s promotion of traditional medicine, countries have been seeking the assistance of WHO in identifying safe and effective herbal medicines for use in national health care systems. In 1989, one of the many resolutions adopted by the World Health Assembly in support of national traditional medicine programmes drew attention to herbal medicines as being of great importance to the health of individuals and communities (WHA 42.43). There was also an earlier resolution (WHA 22.54) on pharmaceutical production in developing countries; this called on the Director-General to provide assistance to the health authorities of Member States to ensure that the drugs used are those most appropriate to local circumstances, that they are rationally used, and that the requirements for their use are assessed as accurately as possible. Moreover, the Declaration of Alma-Ata in 1978 provided for inter alia, the accommodation of proven traditional remedies in national drug policies and regulatory measures. In developed countries, the resurgence of interest in herbal medicines has been due to the preference of many consumers for products of natural origin. In addition, manufactured herbal medicines from their countries of origin often follow in the wake of migrants from countries where traditional medicines play an important role.

In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneficial properties, and possible harmful effects, of all herbal medicines.

The Fourth International Conference of Drug Regulatory Authorities, held in Tokyo in 1986, organised a workshop on the regulation of herbal medicines moving in international commerce. Another workshop on the same subject was held as part of the Fifth International Conference of Drug Regulatory Authorities, held in Paris in 1989. Both workshops confined their considerations to the commercial exploitation of traditional medicines through over-the-counter labelled products. The Paris meeting concluded that the World Health Organisation should consider preparing model guidelines containing basic elements of legislation designed to assist those countries who might wish to develop appropriate legislation and registration.

The objective of these guidelines, therefore, is to define basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines and thereby to assist national regulatory authorities, scientific organisations, and manufacturers to undertake an assessment of the documentation/submission/dossiers in respect of such products. As a general rule in this assessment, traditional experience means that long-term use as well as the medical, historical and ethnological background of those products shall be taken into account. Depending on the history of the country the definition of long-term use may vary but would be at least several decades. Therefore the assessment shall take into account a description in the medical/pharmaceutical literature or similar sources, or a documentation of knowledge on the application of a herbal medicine without a clearly defined time limitation. Marketing authorisations for similar products should be taken into account. (Report of Consultation; draft Guidelines for the Assessment of Herbal Medicines. World Health Organisation (WHO) Munich, Germany, June 1991) ... herbal medicine

Hypo-allergenic

Some excipients used in the manufacture of tablets may have an allergenic effect. They may include additives, colourings, yeast, iodine, etc to which an increasing number of people are allergic. Present-day tablet-makers move away from these chemical binders and fillers, using natural alternatives such as vegetable oils, calcium phosphate, acacia gum and alginic acid from seaweeds. The term also refers to products, including herbal preparations made without sugar, starch, salt, wheat, yeast or artificial preservatives: suitable for vegetarians. ... hypo-allergenic



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