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By Sara Hover, RPh, FAARM, PCCA Clinical Compounding Pharmacist
As modern pharmacy compounding moves into its fifth decade, we have an opportunity to not only look to the future, but also remember the past. There are several innovative dosage forms that compounding pharmacies can create to help patients with health challenges. But to truly appreciate them, and potentially use them as inspiration for future innovations, we need to understand their histories as well as their applications.
I will never forget listening to Bob Boudreaux talk about the mold for rectal rockets that he and his brother, Jerry, had made to help their patients with hemorrhoids. Compounders are true problem-solvers, but this innovation brought that to a new level.
The rectal rocket (pictured above) is a compounded suppository invented by pharmacists Bob and Jerry Boudreaux to help patients with hemorrhoids.
Bob and Jerry, pharmacists from southern Louisiana, recognized there was a problem with how hemorrhoids were being treated. They then envisioned a solution and made it happen.1 The design of the rectal rocket allows medication, such as hydrocortisone and lidocaine, to be in contact with the inflamed tissue both internally and externally at the same time. Prior to the invention of this dosage form, patients had to insert a suppository and use a cream externally. The rectal rocket, on the other hand, allows the medication to stay in contact with the tissue overnight. Developing a dosage form that stayed in one place was a game changer. The rectal rocket even has a vent for patient comfort. It allows air or gas to escape without completely expelling the suppository.
I love to tell the history of this dosage form because it was created by a pharmacist. I might also be a little partial that it was a pharmacist from southern Louisiana, where my family is from. You have to love that Cajun ingenuity!
The Polyox bandage is a mixture of Polyox® WSR-301 and Methocel ® E4M, which creates an anhydrous powder that can be lightly dusted or puffed onto a wound. Polyox is a water-soluble polymer that possesses a unique set of properties, such as quick hydration and adherence to mucosal tissue.2 As this powder hydrates and adheres to a wound, it forms a protective barrier. This “bandage” is resistant to friction, which protects the wound.
The Polyox bandage is a compounded powder often dispensed in a collapsible bottle (pictured above) that allows the patient to puff the custom medication directly onto a wound.
There are many applications of this dosage form. Practitioners will often prescribe the bandage for wound care since many wounds weep or have lots of exudate. The bandage will gel as the wound is releasing fluid. Applying medication to a wound is challenging because rubbing on a cream could disrupt the newly granulating tissue. Dusting on the medication eliminates that concern. Compounders can also add active pharmaceutical ingredients to the bandage that the practitioner prescribes based on the situation. Common active ingredients for these situations include antimicrobials and anesthetics.
This dosage form is also prescribed to treat dental lesions. Mucosal tissue heals very quickly, so many times, just providing the protective covering will reduce pain and facilitate healing.3
Lastly, compounders also use Polyox bandages in veterinary compounding. For example, applying the bandage to a “hot spot” on a dog can aid in the healing. As a deterrent to lick the wound, diphenhydramine can be added due to its bitter taste.
Most compounders dispense the bandage in a collapsible bottle that looks like an accordion (pictured above). This device allows for a slight puff to be applied to the wound or lesion. For optimal results, the patient would puff the bandage on, spritz with a sterile saline solution for irrigation and then reapply the bandage. This process is repeated two more times to create layers of the bandage. If the wound is dry, the process would begin with the saline spray. PCCA members can access our Polyox bandage instructions for patients on our website, which they can print and include with the dispensed medication or use as an example to make their own.
Polyox is used in many industries, including pharmaceutical manufacturing. However, there is nothing like this bandage available commercially for wounds, whether external or mucosal. With having the ability to add the appropriate active pharmaceutical ingredients, compounders can work with prescribers to provide unique solutions for patients.
Two ear, nose and throat (ENT) doctors from California repurposed a nasal insufflator to administer dry powders into the ear canal in the 1950s. 4 Their names were James L. Sheehy and Howard P. House. The device is now called the Sheehy-House insufflator .
The doctors discovered that dusting a small amount of antibiotic, antifungal and steroid as a powder in the ear helped to keep it dry. 4 This dusting can be accomplished by encapsulating the active ingredients into a size 4 capsule and using the Sheehy-House insufflator. As a side note for compounders, the capsule does need to be a size 4 capsule. Even though a size 3 will fit in the device, there is not enough room to allow for the powder to properly flow out of the device. PCCA members can access Sheehy-House insufflator instructions for patients on our website and provide them with the dispensed medication or use them to create their own.
Sheehy-House insufflator capsules consist of a medicated powder dispensed in a capsule that a practitioner or patient can open and then load into a Sheehy-House insufflator (pictured above) so that they can puff the powder into the ear canal for treating otic conditions.
This innovative idea was born out of a problem seen in practice by ENT doctors, and it is still used today. Compounding provides the flexibility to adapt to patient needs with allergies to antibiotics and use the active ingredients the practitioners prescribe.
It is important to know the history of dosage forms and see how they went from an idea to use in practice — you never know when this could spark the next great invention in pharmacy compounding that could help many patients. The three dosage forms I discussed above are prime examples of getting creative to meet patient needs. Innovation is a part of our past, and I’m excited to see how we compounders will continue to creatively help patients in the future. PCCA members can find some commonly requested formulas for these dosage forms in our formula database.
Sara Hover, RPh, FAARM, has been a compounding pharmacist for over 20 years and joined the PCCA Clinical Services team in June 2013. Before joining the PCCA staff, she was the owner and pharmacist of Creative Compounds in Prosper, Texas, an independent, compounding-only pharmacy that focused on women’s health and nutrition. In addition to her expertise in hormone replacement therapy, Sara possesses a vast knowledge of homeopathics as well as herbal and vitamin supplements. Sara obtained her Bachelor of Science degree from the University of Texas at Austin in 1994. She is a lifetime member of the University of Texas College of Pharmacy Alumni Association.
References
1. Vail, J. (2007). The rectal rocket: A two-day treatment for hemorrhoids. International Journal of Pharmaceutical Compounding, 11(3), 194–199. https://ijpc.com/abstracts/abstract.cfm?ABS=2609
2. DuPont. (n.d.). Polyox. IFF Nutrition & Biosciences. https://www.pharma.dupont.com/pharmaceutical-brands/polyox.html
3. Fields, S. W. (2007, February 1). Compounding dental applications. Pharmacy Times. https://www.pharmacytimes.com/view/2007-02-6310
4. Sheehy, J. L., & House, H. P. (1959). Dry treatment of infected mastoid cavities. AMA Archives of Otolaryngology, 70(4), 509–510. https://doi.org/10.1001/archotol.1959.00730040519015