Dr R Valavan, BHMS, MD (Hom), MBA
Head – Scientific & Medical Affairs,
Schwabe India.
drvalavan@drvalavan.in
Homoeopathic post graduate course MD (Hom) was started in 1989 with 3 basic homoeopathic subjects viz. Materia Medica, Organon and Repertory. Later, 4 speciality subjects like Homoeopathic Pharmacy, Practice of Medicine, Paediatrics and Psychiatry were added in 2002. No other country has got post graduate homoeopathy courses with such speciality subjects. There have been amendments in the syllabus of these post-graduate subjects in the last 15 years. Notifications have been published on more specialties including Community Medicine, Pathology, Anatomy, Forensic Medicine, Physiology and Obstetrics & Gynaecology. With time, scope of improvement is felt. Same is true for MD Homoeopathic Pharmacy. To cope up at par with the conventional pharmaceutical industry, homoeopathic pharmacy post-graduates must have knowledge of current pharmaceutical trends and techniques. This article tries to give some inputs for inclusion in the homoeopathic pharmacy syllabus in future. A homoeopathic post-graduate should not only be knowledgeable in homoeopathic pharmacy, but also should aware of the current trends in applied pharmacy.
GMP in homoeopathy
Good Manufacturing Practices (GMP) was notified in homoeopathy around a decade ago and was enforced after two years of notification. GMP calls for amongst other things general requirement for location & surroundings, building, rooms, water, disposal of waste, adherence of factories act, medical services, safety measures, container management & arrangement for personal cleanliness of workers. Standard operating practices (SOPs) for cleaning and sanitation, personal hygiene of the workers, general and specific upkeep of the plant, equipment, premises and every activity associated with manufacture of drugs including procurement, quarantine, testing and warehousing of materials have been prescribed by law. Apart from the location & surroundings and others mentioned in the 3rd paragraph, the industry has to adhere the guidelines such as separate dedicated areas for each ancillary activity like receipt, cleaning, warehousing and issue of raw materials, packaging materials, containers and closures, finished goods, etc.
Measures are being taken to prevent entry / presence, etc. of insects, rodents, birds, lizards and other animals into the raw material handling areas. Every material gets proper identification by control numbers, inventory tags and labels displaying status of the quality being used. Industry now provides proper SOPs for preventing mix-up of materials at every stage of handling with separate arrangements for handling and warehousing of materials of different origins. Materials with odour are kept in tightly closed containers well-protected from other materials. Fresh materials and odourous materials (herbs, flowers, etc.) are stored in separate dedicated areas for their optimum effectiveness. There should always be positive pressure in the production area and negative pressure in the corridors. As per the requirement of the law, the industry has to provide a well-equipped laboratory for quality control / quality assurance of raw materials and finished products and for carrying out in-process controls. In case combinations, which are permitted by Drug Rules as “Formulations”, it requires to be in adherence with the GMP guidelines of potency and Government of India’s guidelines on ethical combination. A homoeopathic pharmacy post-graduate should be well-versed with these aspects.
Modern pharmaceutical techniques
As demand for homoeopathic medicines keeps increasing over the years, the industry has to equip itself to meet the manufacturing demand and supply. Conventional pharmaceutical industry has developed techniques to reduce time and increase efficiency. For example, in the preparation of tablets, granules are dried using conventional tray-driers. It consumes lot of time. Fluid-bed dryers are increasingly used which consumes a fraction of the time taken by conventional tray-driers.
Product development
Product development has taken new dimensions these days. A need for products usually originate based on the market trends. After formula has been finalized considering the respective guidelines, a preliminary feasibility study is done. Once it is found feasible, different compositions are developed for stability. Stability can be accelerated or normal. The most stable product is taken for clinical evaluation. After passing the clinical evaluation, the product is ready for launch. All these processes are with defined timelines. A PERT diagram/chart is first formulated and is strictly followed. Any delay in any stage will further push the launch date.
Formulations of liquid orals like drops and syrups
Many homoeopathic liquid products are either drops or syrups. Syrup is sweet aqueous preparation which is viscous in nature. Though flavoured syrups are available in the market, it is not permitted in homoeopathy. They are suitable mostly for tonics, as cough medications, etc. Though they are of sugar base, dextrose and artificial sweeter based syrups are also available in the market. In liquid orals, solubility and stability of the low potency drugs added in the formulation should be taken into consideration. Many drugs of mineral kingdom are not suitable in low potency. At the same time, current GMP guidelines do not allow the formulations to contain above 3x except toxic substances. Some mother tinctures which are prone to produce sediments have to be carefully looked into.
Use of different additives used in formulations
Now homoeopathic pharmacy has grown-up with supplementary products like health tonics, tissue salts, condition specific products in low potencies, joint pain/massage oils, ear oils, hair oils, beautification products, etc. When a product is developed, knowledge of these additives is required. It helps to finalize additive suitable for the particular product. Some of the commonly used additives are given below:
Globule preparation
Globules have to be comply the specification given in Homoeopathic Pharmacopoeia of India (HPI). Good globule manufacturing practices ensure that they are not at all touched by hand at any stage of production. Homogeneity – variation of size has to be very minimal. Better absorption as directed in the HPI has to be ensured. Test solvent reaches even the centre of the globules during quality control and quality assurance tests. Entire process is done under highly hygienic condition. Only pharma grade sugar is used. Raw materials are thoroughly checked and ensured for highest quality. Controlled Temperature Treatment Technique (CTTT) ensures highest softness of globules. Colour of the globule should be pure natural white. No chemical treatment is done to refine the sugar at any stage.No external material is added to artificially make the globules brighter. The finished product should ensure that there is no microbiological contamination by appropriate microbial tests.
Antiadhesives
| Colloidal silica | Metallic stearates |
| Corn starch | Sodium lauryle sulfate |
| DL-Leucine | Talc |
| Magnesium stearate |
Absorbents
| Bentonite | Magnesiumsilicate |
| Kaolin | Silica |
| Magnesiumcarbonate | Starch |
| Magnesiumoxide | Tricalciumphosphate |
Antioxidants/preservatives
| Acetone | Lecithin |
| Alphatocopherol | Maleicacid |
| Ascorbicacid | Monoisopropylcitrate |
| Ascorbylepalmitate | Nor-dihydroguaiareticacid |
| Benzoin | Phenylalphanapthylamine |
| Beta-naphthol | Propylgallate |
| Butylatedhydroxytoluene | Pyrogallol |
| Butylatedhydroxyanisole | Pyrocatechol |
| Citricacid | Sodiumbisulfite |
| Cysteinehydrochloride | Sodiumformaldehydesulfoxylate |
| Dilaurylthiodipropionate | Sodiummetabisulfite |
| Distearylthiodipropionate | Sodiumsulfite |
| Ethylgallate | Sodiumthiosulfate |
| Gallicacid | Thioglycerol |
| Glycerin | Thiosorbitol |
| Guaiacresin | Thiourea |
| Hydroquinone | Thioglycollicacid |
| Isoascorbicacid | Trihydroxybutyrophenone |
Binders
| Acacia | Ethyl cellulose |
| Alginates | Gelatin |
| CMC | Glucose |
| Hydroxypropyle cellulose | Sucrose |
| Magnesium aluminium silicate | Starch |
| Methyl cellulose | Tragacanth |
| Polyvinylpyrrolidone | Vinyl acetate copolymers |
| Sorbitol |
Coating materials
| Aminoalkyl acrylate copolymers | Lipid cellulose mixtures |
| Cellulose acetate phthalate | Organic acids like benzoic, salicylic naphthoic, fumaric, uric, glutamic asparatic, etc. |
| Cellulose acetate | Polyethylene glycols |
| Epoxy resins | Polyvinylacetates |
| Ethyl cellulose | PVP/PVP modified shellac |
| Ethyl cellulose wax mixtures | Shellac |
| Gelatin | Sodium CMC |
| Half esters of maleic anhydride copolymers | Sodium ethyl cellulose sulfacte |
| Hydroxypropyl methyl cellulose | Styrene-maleic acid copolymers |
| Hydroxyl ethylmethyl cellulose | Sugar |
| Hydroxypropyl cellulose | Terpolymers |
Emulsifying agents
| Benzalkonium chloride | Polyoxyethylene monolaurate |
| Cetrimide | Polyoxyethylene alkylphenol |
| Dioctylsodium sulfosuccinate | Polyoxyethylene sorbitan monolaurate |
| Lecithin | Polyoxyethylene sorbitan monooleate |
| PEG 400 monostearate | Polyoxyethylene sorbitan monopalmitate |
| Polyoxyethylene laurylether | Potassium oleate |
| Polyethylene monostearate | Sodium oleate |
| Propylene glycol monostearate | Sodium lauryl sulphate |
| Propylene glycol monolaurate |
Disintegrants
| Agar | Invertases |
| Alginic acid | Karaya gum |
| Alginates | Locust bean gum |
| Amylases | Microcrystalline cellulose |
| Bentonite | Methylcelluloses |
| Carageenases | Explotab |
| Cellulases | Primojel |
| Carboxy-methylcellulose (CMC) | Pectin |
| Effervescent combinations (organic acids like citric, tartaric in combination with sodium bicarbonate) | Proteases (when gelatin or zein is binder) |
| Guar gum | Tragacanth |
| Hemicellulases | Veegum HV |
Common problems encountered in the product formulation
While developing a product, many a times different problems are encountered which have to be fixed. They include solubility issues, sterility of the products, viscosity and tonicity, etc. A multidisciplinary team has to be formed to look into the product development process. People from different backgrounds like homoeopathy, pharmaceuticals, quality control, chemistry, phyto-pharmaceuticals, etc. should participate and give inputs. Almost every problem has a solution, though it may take some time to reach the desired result.
Medico-marketing
This area has gained much importance in recent years. The concept of publicity has transformed into concept of marketing. It is no longer a choice, but a necessity. These days the organizational goals are majorly dependent on the marketing strategy. Responsibility of a post-graduate homoeopath (pharmacy) will be to screen medico-marketing materials to standardize the contents. There should be a scientific and literature support to any claim. The ethical aspect has also to be looked into. Law of the land has to be followed.
Acknowledgement
Dr. P. N. Varma, for extending his expertise and experience on the subject.
*Based on the article published in Homoeopathy for All, Vol. 18, No 6, June 2016, by the author
Be the first to comment