Changing face of Homoeopathic Pharmacy Different pharmacopoeias

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Changing face of Homoeopathic Pharmacy
Different pharmacopoeia(s)

• Lecture by Dr. P. N. Varma

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Assigned topic Changing face of Homoeopathic
Pharmacy Different pharmacopoeia(s)

• The basic concept 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 or closest to it. It is basis of on
  which standards are fixed.

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Organon aphorisms 264 287 further elaborate the
aim
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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.

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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.

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Legal aspect in India 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 act 1978

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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

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Recognised Homoeopathic Pharmacopoeias

• Homoeopathic Pharmacopoeias recognised by Drugs
  and Cosmetics Act
• Homoeopathic Pharmacopoeia of India (HPI)
• British Homoeopathic Pharmacopoeia (BHP)
• Homoeopathic Pharmacopoeia of United States
  (HPUS)
• German Homoeopathic Pharmacopoeia (GHP)
• French homoeopathic pharmacopoeia is not
  recognised, but it has valuable information on
  nosodes and organotherapies (sarcodes)

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Standardisation

• Standardisation is a process to fix certain
  confirmity to acceptable standards.
• To minimise variation due to individual, group
  or commercial houses influence, the government or
  other statutory bodies notify the acceptable
  standards.

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Standardisation

• As a result the pharmacopoeia that is followed
  have details like
• Genera species
• Synonym common names
• Description data about percentage of active
  ingredient / TLC / chemical identification tests
• Macroscopic and microscopic details
• Methods of preparation / formulation / 2x
  higher methods
• Minimum potency permitted for prescribing in case
  of toxic substances
• Storage condition

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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

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Sources of homoeopathic drugs
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Sources
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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..
  dphtheria)
• N3 for pure organisms (e.g. tuberculinum pure
  culture)
• N4 for preparations from tissues (e.g. psorinum,
  bacillinum)

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Homoeopathic drug proving (HPI Volume 1)

• Controlled experiment
• On relatively healthy volunteers
• Substances should be prepared as per general
  methodology mentioned in the pharmacopoeia
• Experiments should be in varying doses to produce
  the data called proving
• On the scheme and pattern to constitute Materia
  Medica Provings are the basis of Materia Medica
• Experiments should be carried only to extent of
  causing gross temporary reversible alterations
  and sense perceptible objective signs.

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Unique characteristics of homoeopathic drug
standards

• The raw material should be same as used in the
  proving.
• Method of preparation should be one adopted by
  the prover.
• This in turn means
• Go for the correct species, adopt microscopic /
  histopathological studies.
• Fix the percentage of active limits for
  inactive constituents and aducterants.

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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

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Triturations / tablets

• Insoluble basic drug materials (110 or 1100)
  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.

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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

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Lowest potencies legal limits of prescription
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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

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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

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Stringent storage condition (up to 3x)

• Arsenic
• Acid fluric (hydrofluric)
• Atropine sulph
• Chininum ars.
• Lachesis

• Naja
• Nitroglycerine
• Merc. Iod. Flv.
• Merc. Iod. Rub.
• Phosphorus

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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

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Level of testing in homoeopathic drugs

• 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

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No. of homoeopathic drugs covered by different
materia medica other literature large number
is a problem for pharmacopoeia
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No. of homoeopathic drugs covered by different
materia medica other literature contd
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Simplification has been done Hahnemannian
classification of mother tincture preparation
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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

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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.

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German Homoeopathic Pharmacopoeia
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Changing face of German Homoeopathic Pharmacopoeia
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German Homoeopathic Pharmacopoeia contd
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German Homoeopathic Pharmacopoeia contd
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French Homoeopathic Pharmacopoeia

• Gemmotherapie (extraction in glycerine) 56
• Organotherapie (parts of the body similar to
  sarcodes) 261
• Lithotherapie (from crude minerals) - 43

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From HPUS

• In many homoeopathic texts the words potency
  and potentisation, dilution or solution are
  synonymous with the terms attenuation or
  trituration the later terms, by decision of the
  Pharmacopoeia Convention, have become the
  official designations, i.e., attenuation for
  liquids and trituration for solids. In plant
  products, plant moisture was equated to purified
  water. Most of the mother tinctures were
  simplified to drug strength 1/10, exception those
  not soluble like Iodine or those poisonous in
  nature like Arsenic where 1/100 is used.

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Guidelines in evaluating the merit of a drug for
inclusion in pharmacopoeia

• It should be a published data
• It should be a proved drug
• The raw material should be commercially available
  of identifiable characters and of definite
  composition
• It should have a demand to establish professional
  recognition
• Other facts which are considered
• Absence of abnormal toxicity
• Non addict forming in the dosage form
• Stability of the product during production and
  storage

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Thank you