– Sumit Goel.

HOMOEOPATHIC VEHICLES AND BASES

Vehicles used in homoeopathy, which are in the solid state at room temperature, are –

* Saccharum lactis (sugar of milk)

* Cane sugar

* Globules, pilules, pellets

* Cones

* Tablets

SACCHARUM LACTIS

(Saccharum lactose, Lactose, Sugar of milk)

It is a disaccharide containing one unit of betagalactose and one unit of laevoglucose.

CHEMICAL FORMULA: C12H22O11, H2O

MOLECULAR WEIGHT: 360.3

SOURCE AND PREPARATION

* Saccharum lactis is prepared from goat’s milk, which contains lacto-albumin, lacto-globulin, caseinogen, lactose, fats, minerals, salts and water.

* Milk is allowed to stand still, preferably in a cold storage and is skimmed off after the cream has settled. This removes most of the fat content of the milk leaving behind a solid portion of proteins, salts and minerals and a fluid portion of lactose and water.

* This fat-free skimmed milk is treated with dilute hydrochloric acid to precipitate casein. Most of the protein is thus removed by filtration.

* The remaining filtrate is called as ‘whey’. The reaction of this whey is adjusted to a pH of 6.2 by addition of lime. The whole filtrate is then heated to coagulate any further albuminous matter.

* This is then subjected to filtration and the liquid set aside to crystallize. These crystals are redissolved in distilled water and are treated with animal charcoal to decolourize the solution.

* This solution is recrystallized to obtain ‘commercial lactose’.

PURIFICATION

The sugar of milk used for dynamization must be of that special pure quality that is crystallized on strings and comes to us in the shape of long bars. (Footnote no. 150, aphorism 270, 6th edition, Organon of Medicine)

Commercial lactose is not used in homoeopathic pharmacy, as it contains impurities not suitable for homoeopathic use.

Sugar of milk is refined (British Homoeopathic Pharmacopoeia): –

1. By solution in distilled water and careful recrystallization until it assumes the requisite purity and whiteness.

2. By precipitation from a filtered aqueous solution by the addition of rectified spirit, washing the crystalline precipitate with distilled water and drying carefully. It is then pulverized as finely as possible in a perfectly clean mortar and sifted through a fine hair drum-sieve, which must not be used for other purposes. The sugar should be kept in a dry, cool place in well-closed glass jars.

Stapf devised the following method for ‘purification’ of the sugar of milk.

* One pound of crystals of commercial lactose is dissolved in four pounds of boiling distilled water.

* This solution is filtered when it is yet warm.

* The filtrate is then thoroughly mixed with four pounds of absolute alcohol. The whole vessel is tightly kept closed and kept aside so that sugar may crystallize.

* After 3 or 4 days, a thin layer is seen settling at the bottom of the vessel. This crystallized mass is collected and washed in distilled water to which some alcohol is already added.

* These crystals are dried by pressing between filter papers and are preserved for use.

PROPERTIES

* Milky white in colour; its perfect whiteness indicates freedom from fat

* Hard crystalline mass or powder

* Odourless; taste slightly sweet

* Clarity, colour and odour of solution: Dissolve 3.0gm in 10ml of boiling water; the solution is clear, colourless and odourless.

* Sandy or gritty feel on touch

* Stable in air, but readily absorbs odours

* Solubility: 1 gram of sugar of milk is soluble in 5ml of water; in 2.6ml of boiling water; very slightly soluble in alcohol; practically insoluble in chloroform and in ether

* The solution of sugar of milk in water does not form a syrup

* Optical rotation: plus 55.3o at 20oC; it is dextro-rotatory

* Identification:

– When heated, it melts, swells and burns, evolving an odour of burnt sugar and leaving a bulky carbonaceous residue.

– When heated with potassium cupri-tartarate solution, a copious precipitate of cuprous oxide is formed.

* Its solution is neutral to litmus

* Acidity: 5.0gm dissolved in 50ml of freshly boiled water, requires for neutralization, not more than 0.5ml of 0.1N sodium hydroxide, phenolphthalein solution being used as indicator.

* Arsenic: Not more than 1 part per million.

* Sulphated ash: Not more than 0.1 Pecent

PURITY TESTING

Sugar of milk should be checked for impurities like starch, cane sugar, acid radical, alum, chlorides, phosphates, copper, arsenic, sulphated ash.

* Starch: Iodine test – absence of blue colour on addition of a solution of iodine to sugar of milk signifies absence of starch.

* More soluble sugars: Shake 5.0gm with 20ml of alcohol (90 Pecent) for 10 minutes; filter, evaporate 10ml of the filtrate to dryness and dry at 105o; the residue weighs not more than 7mg.

* Cane sugar: addition of cane sugar will impart a sweetish taste to sugar of milk.

* Acid radical: when sugar of milk is prepared from milk that has turned sour, solution will be acidic to litmus.

* Alum: if alum is present, a white precipitate is formed on addition of a small quantity of an alkaline hydrate like a solution of sodium hydroxide.

* Chlorides and phosphates: these can be detected by the formation of a precipitate on the addition of a solution of silver nitrate to sugar of milk.

* Copper: Dissolve 2gm in 20ml of water, add 1ml of dilute hydrochloric acid and 10ml of solution of hydrogen sulphide; no colour is produced.

UTILITY

* The preservative properties of sugar of milk are superior to cane sugar and most other substances, keeping the minutest particles of triturated metals untarnished by oxidation, for an indefinite time. Even readily deflorescent substances like potassium iodide and others that are easily decomposed, are preserved by trituration with equal parts of milk sugar, even if kept in paper capsules, for a much longer time than without the milk sugar.

* Sugar of milk is devoid of all medicinal action. Its crystalline particles are very hard and gritty and hence are of great use in grinding down the particles of drugs submitted to the process of trituration.

* Drug substances those are insoluble in liquid vehicles like water and alcohol are triturated with sugar of milk. Mother substances, according to class VII, class VIII and class IX are prepared with sugar of milk.

* Sugar of milk is an important solid dosage form for dispensing of homoeopathic medicines.

* Sugar of milk can also be dispensed as placebo.

* Sugar of milk is used for the preparation of tincture triturates, tablet triturates and tablets.

* It is devoid of fat and as such may be used as a temporary diet for babies who cannot tolerate milk.

“INERT NATURE OF SUGAR OF MILK”

Hahnemann, in ‘Chronic Diseases ‘, comments –

There were some anxious purists, who were afraid that even the pure sugar of milk, either in itself or changed by long trituration, might have medicinal effects. But this is a vain, utterly unfounded fear, as I have determined by very exact experiments. We may use the crude, pure sugar of milk as a food, and partake of considerable quantities of it, without any change in the health, and so also the triturated sugar. But to destroy at the same time the fear to which utterance has been given by some hypochondriacs, that through a long trituration of the sugar of milk alone, or in the potentizing of medicines, something might rub off from the porcelain mortar (silica), which being potentized by this same trituration would be bound to become strongly acting Silicea; I took a new porcelain triturating bowl in which the glazing had been rubbed off, with a new porcelain pestle, and had one hundred grains of pure sugar of milk, divided into portions of thirty-three grains, triturated eighteen times for six minutes at a time and as frequently scraped for four minutes with a porcelain spatula, in order to develop by this three hours’ strong trituration a medicinal power either of the sugar of milk or of the silica or of both. But my preparation remained as indifferent and unmedicinal as the crude, merely nutritive sugar of milk, of which I convinced myself by experiments on very sensitive persons.

STORAGE – Preserve in well-closed containers, in a dry cool place.

CANE SUGAR

(Sucrose)

CHEMICAL FORMULA : C12H22O11

MOLECULAR WEIGHT : 342.3

SOURCE

Sucrose is a sugar obtained from

* Saccharum officinarum (family – Graminae): sugarcane:- (-D-glucopyranoside

* Beta vulgaris (family – Chenopodiaceae): beet sugar:- (-D-fructofuranosyl

PREPARATION

Commercially, sucrose is obtained from sugarcane, beet root and sorghum. Originally, sugarcane was the only source, but at present, the root of Beta vulgaris is used largely in Europe.

* The sugarcane is crushed and the juice amounting to about 80 Pecent is expressed with roller mills.

* The juice, after ‘defecation’ with lime and removal of excess of lime by carbonic acid gas, is run into vacuum pans for concentration.

* The saccharine juice is evaporated in this until it begins to crystallize.

* After crystallization is complete, the warm mixture of crystals and syrup is run into centrifuges in which the crystals of raw sugar are drained and dried. The syrup resulting as a by-product from raw sugar is known as ‘molasses’. Raw beet sugar is made by a similar process.

* The refined sugar from either sugarcane or beet sugar is prepared by dissolving the raw sugar in water, filtering and finally decolourizing the solution by passing it through bone-black filters.

* The water-white solution is evaporated under reduced pressure to the crystallizing point and then forced to crystallize in small granules that are collected and drained in a centrifuge.

PROPERTIES

* Colourless or white crystals, crystalline masses or blocks or a white crystalline powder

* Odourless; sweet taste

* Stable in air

* Solution neutral to litmus

* Melts with decomposition from 160 – 185oC

* Specific gravity: 1.57

* Solubility: 1gram of sucrose is soluble in 0.5 ml of water; in slightly more than 0.2 ml of boiling water; in 170 ml of alcohol; insoluble in chloroform and ether

* Optical rotation: not less than plus 65.9o at 20oC

Identification

When heated, it melts, swells up and burns, giving off an odour of burnt sugar and leaving a bulky carbonaceous residue.

UTILITY

* Cane sugar is used for the preparation of globules, pellets and cones.

* It is used for making syrups as it gives viscosity and consistency to fluids.

PRECAUTION

The crystals of cane sugar are fermentable and break into alcohol and eventually into acetic acid, if not properly stored.

GLOBULES, PILULES, PELLETS

SOURCE

Globules are prepared from pure cane sugar (pharmaceutical grade of cane sugar / sucrose). It is sometimes made with 80 Pecent sucrose and 20 Pecent lactose.

PREPARATION

* Granulated cane sugar is placed in a rotating stainless steel globule-making pan or pill tubes and rolled until the granules are formed into spherical shape.

* Purified water is injected as the tube rotates. The size of the globule depends on the water spray. The size of the globule will be bigger if the water spray is more.

* When the required size globules are formed, they are removed to a hot chamber, where they become dry.

* After drying is complete, the globules are made to pass through sieves having various size meshes.

PROPERTIES

* Colour: white; all pellets moistened with the spirituous liquid have when dry a dull appearance; the crude unmoistened pellets look whiter and more shining.

* Shape: The globules should be uniform and perfectly globular, i.e. the diagonal diameters measured with the help of screw gauge shall not vary more than 10 Pecent between them.

* Size: Globules should be of uniform size, normally designated as numbers; The claimed size is determined as follows: Lay 10 globules in close contact with each other, diameter to diameter; the space so occupied is measured in millimeters by a suitable caliper and the measure is designated as numbers (Permitted variation plus /_ 10 Pecent).

Globules are about the size of poppy seeds and pilules are a little larger. Size numbers 40, 50, 60, 70 or 80 are generally called pilules. The smaller sizes are called globules.

Hahnemann, as we learn from his writings, used globules of various sizes. Those for administration by the mouth he usually describes as the size of a poppy seed. He states them to be of the weight of 300 or 200 to the grain and says that 300 of them are sufficiently moistened by one drop of alcohol. Those for olfaction, he usually states to be of the size of a mustard seed.

Hahnemann, in the 6th edition of Organon of Medicine, aphorism number 270, under the new method of developing the medicinal power, advises the use of the small sugar globules for medication – they are prepared under supervision by the confectioner from starch and sugar and the small globules freed from fine dusty parts by passing them through a sieve; then they are put through a strainer that will permit only 100 to pass through weighing one grain, the most serviceable size for the needs of a homoeopathic physician.

* Consistency: hardness – should not be too soft or too hard

* Odour: odourless

* Taste: sweet, as it is made from cane sugar

* Solubility: entirely soluble in water

* Porosity: should be capable of impregnation as evidenced by capacity to absorb 0.1 Pecent methylene blue solution to the center of the sphere within 30 seconds (cut by a blade to observe)

* Sugar content: not less than 99 Pecent of the claimed amount Impurities

Foreign matters: globules should not contain any of the following substances –

1. Flavour

2. Starch

3. Glucose

4. Glycerin

5. Talc

6. Chalk

7. Kaolin

8. Antioxidants

9. Inorganic and synthetic whitening agents

PELLETS

Pellets are small, sterile cylinders about 3.2 mm diameter by 8 mm in length that are formed by compression from medicated masses. In homoeopathy, it is a synonym for ‘globule’.

UTILITY

* Dispensing of homoeopathic potencies as well as placebo. They are a convenient dosage form with ease in dispensing, storage, carriage and usage.

* A good media for preservation of homoeopathic medicines.

PRESERVATION

* After medication, the excess is poured out and the globules are dried on a filter paper and filled in a clean phial.

* Globules are to be kept in airtight bottles and kept away from moisture.

* The globules retain their medicinal value for many years, if protected against sunlight and heat.

Globules have to be discarded, in any of the following conditions –

* When there is a change in the colour of the globules, i.e. they become ‘yellow’.

* When the globules stick to each other or to the walls of the container. This occurs when the globules absorb moisture or the water content in the medication is high. Globules do not stand medication in these cases.

* When there is a change in the taste or the odour of the globules.

* Presence of impurities.

CONES

SOURCE

Cones are made of cane sugar and rendered more absorbent with the addition of a small quantity of egg albumin, which makes them very light and porous.

PROPERTIES

* Shape: conical or hemispherical masses

* Size: cones are designated according to size by the diameter of base in millimeter; the common size, numbered 6, should absorb about 2 drops of dispensing alcohol

UTILITY They are used for preservation of medicines for a long time.

STORAGE

To prevent fermentation, cones should be kept in a dry atmosphere.

TABLETS

Tablets are solid masses that are made by the compaction of a suitably made medicament by a tablet machine. Although tablets may be manufactured in wide range of shapes, officially tablets are unit forms of solid medicinal substances and defined as circular discoids with either flat or convex faces.

SOURCE

Tablets are prepared from pure refined sugar of milk.

QUALITIES OF A TABLET

A satisfactory tablet should have the following properties

* It should contain the correct dose of the drug.

* It should not contain any unnecessary excipients.

* It should be capable of being handled and transported without crumbling.

* It should possess a smooth and uniform surface.

* It should disintegrate readily after administration.

* It should have a reasonable shape and size for convenient administration.

PROPERTIES OF HANDMADE AND COMPRESSED TABLETS

* Shape: discoid, round with flat or convex face

* Size: they are found in size of 1grain or 65 mg

* Weight variation: weigh 20 tablets and find out the average weight; when

* weighed singly, not more than two of the tablets should deviate from the average weight by 10 Pecent.

* Consistency: softer than globules, as they are made of sugar of milk; they are also less sweeter.

* Solubility: more easily soluble in water than globules; insoluble in alcohol.

* Drug content: it should contain the claimed medicine determined by known assay methods for the concentration manually or by using a suitable instrument; permitted variation is (+/_) 5 Pecent.

* Lactose content: not less than 94 Pecent.

* Binder: not exceeding 3 Pecentw/w.

* Lubricants: not exceeding 3 Pecentw/w.

* Insoluble matter: not exceeding 5 Pecentw/w.

* Absence of sucrose and starch.

* Talc: should give negative test for magnesium silicate.

* Chalk: should give negative test for carbonates and calcium except in Calcarea group of drugs where calcium content should be proportionate to claimed calcium as a drug.

* Kaolin: should give negative test for aluminium.

* Disintegration time / Dissolution time: compressed tablets should pass the tests for disintegration time within 5 minutes.

* Ash value: handmade tablets – not exceeding 0.1 Pecentw/w; compressed tablets – not exceeding 0.5 Pecentw/w

UTILITY

Tablets serve as solid dosage forms for dispensing of homoeopathic medicines.

ADVANTAGES

* When correctly formulated and manufactured, tablets provide an accurate and stable dose of a drug.

* They can be conveniently carried by the patient.

PRESERVATION

Tablets should be preserved in well-closed containers and not to be tightly packed.

SELF ASSESSMENT

* Describe preparation, purification, properties and uses of sugar of milk.

* Discuss standardization of sugar of milk.

* What are the impurities in sugar of milk and how will identify them? Describe Stapf’s method of purification.

* What are vehicles? Discuss cane sugar in detail.

* Discuss preparation and properties of globules / cones / tablets

QUIZ

1. Cane sugar with egg albumin is used to prepare

(a) Globules

(b) Pellets

(c) Cones

(d) Tablets

2. Tablets are mostly prepared from

(a) Sugar of milk

(b) Cane sugar

(c) Sugar of milk and egg albumin

(d) Cane sugar and egg albumin

3. Gritty feel to touch is a property of

(a) Cane sugar

(b) Sugar of milk

(c) Starch

(d) Talc

4. Cane sugar is prepared from

(a) Beta vulgaris

(b) Goat’s milk

(c) Molasses

(d) Cannabis sativa

5. 1 gram of sugar of milk is soluble in

(a) 0.2 ml of boiling water

(b) 0.5 ml of boiling water

(c) 1 ml of boiling water

(d) 2.6 ml of boiling water

ANSWERS: 1 (c); 2 (a); 3 (b); 4 (a); 5 (d).

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