Changing Face of Homoeopathic Pharmacy

Lecture by Dr. P. N. Varma

Changing face of Homoeopathic Pharmacy

The basis of homoeopathic medicine is

Experimental Pharmacology (Proving as

known in homoeopathy).

This essentially calls for that the raw

material should be one used in the

proving

Standards are fixed to ensure that the aim of original drug is achieved

It takes into consideration.

a) Organon aphorisms 264 to 287

b) The availability of situation

c) Pharmaceutical aspects of preparation

without losing the original medicinal

power

Organon aphorisms 264 – 287 further elaborate the aimGenuineness, authenticity and standard quality (unimpaired strength)

§ 264 – 265

The product should be in natural & crude state § 266

Prepared as per methods of… (homoeopathic pharmacopoeial technique)

§ 267

Used in dose sufficient to initiate the drug action § 283

Material quantity MT and minor variation is of no significance (provided not used for pharmacological effects)

§ 284

Dilution or potentisation increases effect § 286-287

Standard products…

In other words standard products, in natural

form, in its totality, in dose to initiate

mechanism of cure by qualitative action mainly

in “dose” which does not have side effects.

Methods for testing the products for their purity

and absence of impurity form the basis of

pharmacopoeia.

Pharmacopoeias

Dr. Caspari (1825) and Dr. Willmar Schwabe (1872)

did leave pharmacopoeias but it was AHP 1897

which seriously dealt with individual drugs, its

identification & preparation . HPUS 1941 was taken

up by the FDA Act 1938 (In India Drugs were

controlled in 1940). HPI came in 1971 with methods

of preparation and 180 monographs of drugs. With

this the homoeopathic pharmacy shifted from “art” to

“science”.

Legal aspects of homoeopathy in India

Homoeopathy in India comes under Drugs and Cosmetics

Act. It recognises the following pharmacopoeias:

1. Homoeopathic Pharmacopoeia of India (HPI)

2. British Homoeopathic Pharmacopoeia (BHP)

3. Homoeopathic Pharmacopoeia of United States (HPUS)

4. German Homoeopathic Pharmacopoeia (GHP)

French homoeopathic pharmacopoeia is not recognised, but

it has valuable information on nosodes and

organotherapies (sarcodes)

The Drugs and Cosmetics Rules 1945

“Homoeopathic medicines” include any drug which is recorded

in Homoeopathic provings or therapeutic efficacy of which has

been established through long clinical experience as recorded

in authoritative Homoeopathic literature of India and abroad

and which is prepared according to the techniques of

homoeopathic pharmacy and covers combination of ingredients

of such Homoeopathic medicines but does not include a

medicine which is administered by parenteral route.

Sources of homoeopathic drugsEarlier Now

Plant sources Allersodes

Animal sources

Minerals Isodes (tautopathic medicines can be classified along with isodes as the method of preparation is same)

Nosodes

Sarcodes

Imponderabilia

Sources…

Sarcodes Properly identified healthy organs or tissues

Needs healthy certificate & genuinity by

experts before a drug is made (legal need)

Imponder-

abilia

No more vague. In revision series of HPUS

like for X-Rays. 1 liter or 1 kg is exposed to

1000 X-Ras rads to make basic material for

use. It is then diluted as 1/100 and product

is equalant to 2x

Nosodes – methods of preparation

N1 for the lysate of bacteria producing endotoxins (e.g..

Typhoid, paratyphoid, e.coli)

N2 for bacteria producing exotoxins (e.g.. diphtheria)

N3 for pure organisms (e.g. tuberculinum pure culture)

N4 for preparations from tissues (e.g. psorinum,

bacillinum)

Gradual enforcement of Act & Rules

Homoeopathic medicines were

defined in Drug Rules (Rule 2 dd)1969

Homoeopathic pharmacopoeia

covered in the second schedule

of the act1978

Homoeopathic drug proving (HPI Volume 1)

1. Controlled experiment

2. On relatively healthy volunteers

3. Substances should be prepared as per general methodology mentioned in the pharmacopoeia

4. Experiments should be in varying doses to produce the data called ‘proving’

5. On the scheme and pattern to constitute Materia Medica Provings are the basis of Materia Medica

6. Experiments should be carried only to extent of causing gross temporary reversible alterations and sense perceptible objective signs.

Unique characteristics of homoeopathic drug standards

1. The raw material should be same as used in the proving.

2. Method of preparation should be one adopted by the prover.

This in turn means:

1. Go for the correct species, adopt microscopic / histopathological studies.

2. Fix the percentage of active & limits for inactive constituents and aducterants.

Process has a bearing on the quality

Trituration - particle size 10 micron at 1x level

Tincture - fresh or dry plant

- size of cut or fineness of the powdered material

- percolator packing

- percentage of extraction solvent

- rate of percolation

- time of maceration

Supplementary but essential standards

Ash values

Extractive values

Saponification values

Reaction (pH) of known strength solution

Foreign matters

Moulds, fungus, bacterial, pesticide residue TLC Rf values

Tincture, odour, taste, colour & dry residue

Triturations / tablets Insoluble basic drug materials (1:10 or 1:100) with

lactose Triturated by hand or machine. Particle size of the

basic drug material in the final decimal or centesimal dilution has to be below 10 µm for 80%; no drug particle should be more than 50 µm.

Trituration time: Minimum 1 hour. One third of the lactose is given into the mortar, then

the basic material is added; finally the remaining vehicle in two equal portions is added and triturated.

Triturations / tablets contd…

For tabletting permitted excipients are only starch – concentrated up to 10 percent and magnesium stearate in concentrations up to 2 percent.

Granulation if necessary has to be done with saturated lactose solution, starch paste or ethanol.

Tablets are single doses containing 250 mg of the trituration. The weight of excipients goes additional.

Lowest potencies – legal limits of prescription

Name of the drug Legal position

Antim. ars. Not below 3x

Ars. Alb. Not below 3x

Ars. Iod. Not below 3x

Ars. Sul. Flv. Not below 2x

Ars. Sul. Rub. Not below 2x

Baryta carb. Not below 3x

Baryta mur. Not below 3x

Bufo rana Not below 3x

Calcarea ars. Not below 3x

Lachesis Not below 6x

Lowest potencies – legal limits of prescription contd…

All arsenic, barium, mercury and lead – not below 3x

All nosodes - not below 6x (3rd potency) for trading, not below 6th potency in practice

All snake, viper, spider, toad and insect poisons - not below 3x (exceptions in India – Blatta orientalis Q)

Phytochemicals (HCN glyc.) etc. – not below 6x

Special storage conditions (up to 3x)

Acidum aceticum, nitricum,

picrinicum and sulphuricum

Apis mellifica

Bromine

Creasole

Gelsemium

Hydrastis

Iodium

Physostigma

Rauwolfia

Secale cor.

Zincum aceticum

Stringent storage condition (up to 3x)

Arsenic

Acid fluric

(hydrofluric)

Atropine sulph

Chininum ars.

Lachesis

Naja

Nitroglycerine

Merc. Iod. Flv.

Merc. Iod. Rub.

Phosphorus

Level of testing in homoeopathic drugs

Biochemic drugs - up to 6x; up to 12x by plasma

Triturations - up to 6x; up to 12x by plasma

Mother tinctures - up to 4x; up to 6x by HPLC

Mother tinctures - up to 2x in combinations

Combination drugs - up to 2x

Ointments, hair oils, eye drops, etc.

Dilutions - up to 6x

Level of testing in homoeopathic drugs Contd… Molecules are present at best up to level 12C

or 24x But clinical response is visible even above

24x in• Human being • Animals • Bacteria• Plants

Biological response can be demonstrated on polygraph and other sensitive equipments used in experimental pharmacology

No. of homoeopathic drugs covered by different materia medica & other literature

Materia medica No. of drugs covered

Materia Medica Pura – Hahnemann

75 approx.

Lectures on Materia Medica – J. T. Kent

206

Encyclopedia of Pure Materia Medica – T. F. Allen

720

Dictionary of Practical Materia Medica – J. H. Clarke

1010

Pocket Manual of Homoeopathic Materia Medica and Repertory – W. Boericke

1235 + 200 in footnote

No. of homoeopathic drugs covered by different materia medica & other literature contd…

Homoeopathic Pharmacopoeia of India

845 (total no. of monographs is 916, but it has repetition of many drugs in subsequent volumes)

Homoeopathic Pharmaceutical Codex, volume 1

101

Homoeopathic pharmacopoeial list (Govt. of India)

2373

HPI drug documentation file 4400

OLD METHOD – No more used Hahnemannian classification of mother tincture preparation

Class Ratio of vehicle Drug strength

Drug under the class

Class I Juice:alcohol 1:1 1/2 Belladonna

Class II Plant:alcohol 3:2 1/2 Thuja

Class III Plant:alcohol 1:2 1/6 Scilla

Class IV Dry Plant:alcohol 1:5 1/10 Spigelia

Class V A Aqueous solution 1:9 1/10 Acid phos

Class V B --do– poisonous 1:99 1/100 Hydrocyanic acid

Class VI A Alcoholic solutions 1:9 1/10 Chromic acid

Class VI B --do– poisonous 1:99 1/100 Arsenicum

Class VII Trituration 1:9 1/10 Strychninum ars.

Class VIII --do– liquid subs. 1:99 1/100 Petroleum

Class IX --do– veg & animal 2:99 2/101 Agaricus

New concept: On uniform drug strength…

Materia Medica Pura Vol II pg 30 or Chronic

Diseases pg 182 :

“In order to make alcoholic medicinal

substances of uniform strength and to obtain

from them determinable dilution follow….”

BHP part I pg 11 & 12 :

“In every substance the dry crude substance is

to be taken as starting point for calculation of

strength.”

German Homoeopathic Pharmacopoeia

Method Proportion Drug strength

I Juice + alcohol 86%M

ac

era

tion

1:1

II A Fresh drug + alcohol 86% 1:2

II B Fresh drug + alcohol 30% 1:2

III A Fresh drug + alcohol 60% 1:2

III B Fresh drug + alcohol 73% 1:2

III C Fresh drug + alcohol 43% 1:2

German Homoeopathic Pharmacopoeia Contd…

Meth-od Proportion

Drug strength

IV A Dry drug : alcohol 1:9 1/10

IV B Dry drug (animal products) : alcohol 1:9 1/10

V A Solutions – alcohol, water or glycerol 1/10 or 1/100 1/10 or 1/100

V B Solution aqueous water for injection 1/10 or 1/100 1/10

VI Trituration 1/10 or 1/100 1/10

VII Trituration of MT or MS 1x

VIII Liquid from trituration 8x or 4C

VIII B Liquid from trituration – in water for injection

IX Tablets permitted starch up to 10% calcium bihanate or magnesium stearate 2%

German Homoeopathic Pharmacopoeia contd…

Method Proportion Drug strength

X Granules

XI Liquid dilution for injection

XII A External application MT (alcohol 30-43%) 1/10

XII B External application MT (alcohol 73%) 1/10

XII C External application MT (alcohol 20%) 1/10

XII D External application MT in oil 60-70°C 4 hours

XII FL External application MT in oil under CO2 37°C 7 days

XIII B Ointments – antioxidants, stabilizers are not permitted

German Homoeopathic Pharmacopoeia contd…

Method Preparation

XIV Suppositories – antioxidants, stabilizers are not permitted

XV Eye drops – Isotonic, sterile, preservatives permitted

XVI Mixtures

XVII A LM potencies

XVII B LM potencies in granules

XVIII A,B,C,D,E&F Heat treated liquid tinctures

XIX A,B,C,D,E&F Refluxed tinctures

XX Refluxing and cooling – Rh MT

XXI, XXII, XXIII& XXIV For different set of alcohol % - Rh MT

XXV to XXXVIII Spagric MTs – fermented products

XXXVII to XXXIX Coated granules

XL (40) Potentised mixtures

XLI to XLVI Nasal drops, i.v. drops, etc

French Homoeopathic Pharmacopoeia

Gemmotherapie (extraction in glycerine) – 56

Organotherapie (parts of the body – similar to

sarcodes) – 261

Lithotherapie (from crude minerals) - 43

Quotation from HPI Vol II

“The old Hanemannian method of preparation has been

discarded in favour of a new uniform method with specific

drug strength which takes in to consideration the moisture

content of the drug, thus eliminating the variation in

standards. This method (the new uniform method of

preparation of tincture as mentioned in the General

Instructions for preparation in Homoeopathic

Pharmacopoeia) is applicable to most* of the drugs and has

been accepted by the committee”.

*A few exceptions have been taken care in the individual monograph

GMP

There have been amendments to

Drug Rules in October 2006

affecting homoeopathic medicines

– Good Manufacturing Practices

(GMP)

GMPGovernment now differentiates

single medicines and formulations

It now differentiates indirectly low

potencies and high potencies

It now requires that the containers should be neutral glass

In the manufacturing area no spitting, smoking, chewing, littering, etc. are permitted.

GMP

A standard operating practices

(SOPs) is required for all processes,

drugs and material movements.

GMP

The manufacturer shall use back-

potencies procured from licensed

manufacturers and the firm shall

maintain proper records of purchase or

shall prepare own back-potencies with

records.

GMP

Different droppers shall be used for different medicines and different potencies.

Potentisation shall be done using Hahnemannian method (change of bottle at each stage of potentisation)

GMP

In case of formulation the following has been added:

Compound formulations shall preferably be in liquid and

solid forms and the potency of the ingredients shall be in

detectable quantity preferably be in 3x except in case of

highly poisonous material and toxins which should not be

below 6x.

The ingredient shall be compatible to each other.

Complete pharmacopoeial name of each ingredient shall

be printed on the label along with composition.

GMP

In case of Laboratory Controls the following the following has

been added:

Tests as per the pharmacopoeia and requirements shall be

carried out on products and materials.

The stability of the products shall be established by proper

methods.

Sterility tests, wherever applicable, shall be carried out.

Control samples shall be preserved for not less than three

years after the last sales.

GMP

For the first time expiry date

for homoeopathic medicines

has been prescribed.

GMP

Thank you.