mortarPharmaceutical compounding is the creation and dispensing of custom-made medications. It is at the root of the pharmacy profession and is often symbolized by the mortar and pestle. The practice involves mixing, measuring, and making safe, well-designed pharmaceutical dosage forms. It is an important practice for many patients who find it hard to take traditional medication such as paediatric patients, hospice patients, and patients allergic to common dyes and fillers.

Compounding has come under increasing regulatory examination over the past ten to fifteen years due to various risks involved in the practice. Traditional FDA regulation of compounding practice is not viable, given the time and resources needed for drug approval. However, FDA has the statutory authority and discretion to regulate the practice in this manner. New regulation, withdrawing compounding from traditional FDA regulation, is essential to protect patient access to this important practice. Moreover, pharmacists need clear guidelines for proper practice and patients need guarantees of product safety.

Some parts of dermatology compounding have been discussed in this article for your reference.

Oral Drops:

In his book on Bio-identical Hormones, Uzzi Reese, MD makes full use of oral drops. He gives the patient a few drops of estrogen or Progesterone solution to put under her tongue for oral absorption. Since he had only one patient who was using this method, she kept changing her dosage from day to day, and even hour to hour. She was continuously getting hot flashes also.

I think the main drawback is the difficulty of giving a consistent dose. With practice, the method could be made to work more consistent methods of administration that are superior.

Topical Creams:

A majority of steroid hormones can be given as topical creams. There are numerous commercially available formulas. So, if a given patient is allergic to one type, it can be replaced with another.

Other pharmacies make available small measuring spoons. The pre-filled syringe is best to administer, most accurate and easiest for patients to use. The cost may be slightly higher because a lot of syringes have to be provided. The pharmacists use a wide bore needle to load the syringes from the inside.

Advantages:

Because the creams are placed topically and spread into the bloodstream, the first-pass effect is evaded. Another advantage is changeability of dosing. If a patient is accepting too much or too little medication, the dose can be adjusted by changing the quantity used without requiring the patient to take a new prescription. Doses can also be divided and used many times a day. This patient controlled freedom is a helpful feature. But to use multiple capsules every day will increase the cost.

Disadvantages:

There is greater inconsistency of absorption with creams than any other methods. In most cases, thin skinned white women have the greatest absorption in comparison to the well tanned skin. It is difficult to know if it is the patient, the application technique, skin type, or the cream itself, that is at fault leading to poor results. Therefore, obtaining blood levels to authenticate hormone absorption is a must.

Creams may be messier and time taking to apply than swallowing a tablet or a capsule. Since I believe that assimilation through the palm is important, this prevents the patient from immediately washing her hands. Also, touching another person immediately after application of cream might transfer some of the hormone to another individual.

Application:

There is a little disagreement about the best method and site for application. It is often recommended to apply creams to thin skin areas over a good vascular supple. These areas are the forearm, the back of the knee, and inside the elbow. Others suggest application to areas overlying thick layers of fat; for example; the thigh and buttocks.

In measuring blood levels and asking patients to show him exactly how they apply the creams, he has come to his own conclusions. He believes that the palm of the hand actually is the main spot of absorption. He advises patients to measure out the cream into the palm of their hand and briskly rub it onto another surface like the opposite forearm or the thigh. Some patients would place the cream on one forearm and rub it with the other forearm. These women always have very low levels of the prescribed hormones and as such, I do not advocate the forearm-to-forearm technique.