• Attenuation methods: Hahnemannian and Korsakovian

The two principal methods for manufacturing homeopathic liquid pharmaceuticals are the Hahnemannian and the Korsakovian Methods of Attenuation. The Hahnemannian method utilizes a new container for each attenuation step, requiring the measurement of 1 part of the previous homeopathic potency and the appropriate amount of the diluent to create the next homeopathic potency after succussion (9 parts for X or D potencies, 99 parts for C potencies). Homeopathic drug products manufactured by that method may include the letter H in the potency designation, e.g. 6DH or 9CH to indicate that the Hahnemannian method has been employed.

The Korsakovian method utilizes the same container for each attenuation; it typically is used with the centesimal scale of attenuation. That requires emptying the container so that 1 part of the previous homeopathic potency adheres to the wall of the container.

By adding 99 parts of diluent to the container, the next serial 1:100 dilution is created for succussion. Homeopathic drug products manufactured by this method include the letter "K" in the potency designation, e.g. 3CK.

Dosage forms

Once attenuated to the desired potency, homeopathic pharmaceuticals can be processed into a variety of dosage forms including: triturate tablets, compressed tablets, medicated tablets, lozenges, capsules, powders, medicated pellets (globules), oral liquids, syrups, ophthalmic solutions, nasal sprays, ointments, creams, gels, injectables and suppositories. The most common dosage forms are tablets, pellets and liquids.

Triturate tablets are manufactured by adding a binder (typically alcohol and natural gum acacia or sucrose) to the triturated powder and molding the moistened powder into the shape of a tablet, which is then dried, much like a nitroglycerine tablet. The soft triturate tablets typically utilize only lactose as the base of the tablets and do not require other excipients to which the patient may be sensitive. Triturate tablets dissolve almost instantly in the saliva of the mouth, facilitating sublingual absorption. Because of their friable nature, triturate tablets are currently exempt from FDA tablet imprinting requirements.

Compressed tablets are produced by mixing the triturate powder with other excipients and then using pressure to stamp the mixture into a hard tablet that may be swallowed or chewed and dissolved in the mouth. Additional excipients may be required to facilitate powder flow through the machine (e.g., magnesium stearate) and to enhance disintegration of the tablet (e.g., starch). Compressed tablets must include an imprinted code on their surface to identify the manufacturer and homeopathic nature of the tablet.

Medicated tablets can be prepared by applying a homeopathic medicated solution to saturate the surface of an unmedicated compressed tablet. The tablets are dried, leaving the homeopathic medicine in the surface layer of the tablet. As an alternative, the homeopathic component can be added to the tablet mass before compression.

The medicated pellet or globule is probably the most extensively used homeopathic dosage form. First, an unmedicated pellet is formed by accumulating sucrose and lactose solutions onto the surface of a seed crystal in a rotating coating pan until it reaches the desired diameter or size. Then, the pellets are prepared by applying the homeopathic medicated solution of specific potency to saturate the surface of the unmedicated pellet. Medicated pellets are designed to be dissolved in the mouth for sublingual absorption of the homeopathic medicine.

Medicated Pellets are manufactured in various sizes e.g. #10 pellets (very small), #20 pellets (small), #35 pellets (regular) and #55 pellets (large). While the diameter of the medicated pellet differs from size to size, the dose delivered by each pellet is considered equivalent. The different sizes are made available to accommodate personal and professional preferences, such as very small pellets for children or pets and regular pellets for ease of counting out the dose.

Oral liquid dosage forms, often referred to as dilutions, are prepared by dispensing the homeopathic attenuation in a base of 20 percent ethanol. While 87 percent alcohol dilutions also are offered, their alcohol bite on the tongue makes them better suited for further attenuation applications. The alcohol in that dosage form is used as a diluent in the attenuation process and also functions as the preservative system for the dosage form. While liquid homeopathic products must comply with FDA labeling requirements for alcohol content declaration, they are exempt from FDA alcohol content limits. This is due to the minute amount of alcohol delivered when this dosage form is used in four-drop to 10-drop quantities and the HPUS/RS requirement for alcohol in the attenuation process. Glycerine also can be used in lieu of alcohol for some liquid homeopathic dilution formulations.

Additional dosage forms such as topicals, powders, capsules, ophthalmic solutions, injectables and suppositories are manufactured in much the same way as allopathic drugs, with the use of the homeopathic attenuation as the active ingredient. The same excipients and preservative systems are used with similar cGMP compliant manufacturing processes and quality control specifications.