Compounded dosage forms which are used for the treatment of erectile dysfunction

Erectile dysfunction (ED) is a condition characterized by the repeated inability to achieve or maintain an erection during sexual activity. The disorder is prevalent, affecting an estimated 52% of men between the ages of 40 and 70¹.

Conventional dosage forms for ED treatment

Until now, there have been three primary dosage forms for the pharmaceutical treatment and management of ED:

1. Injection therapy: The active pharmaceutical ingredient(s) (API) is administered via intracavernosal injection.
2. Intraurethral therapy: An applicator system is inserted through the urethra, where the API is absorbed and distributed to surrounding tissue to promote blood flow.
3. Oral therapy: Typically, a tablet, capsule, or liquid.  

Drawbacks to conventional ED dosage forms

While injections and intraurethral treatments are fast-acting and highly effective in delivering the API to the local area, they have significant potential drawbacks, including the possibility of administration anxiety, severe pain, and scarring at the injection site². Moreover, if there is partial dissolution, this can result in unsatisfactory or partial erection³.

This leaves oral administration of tablet PED-5 inhibitors to treat ED as the most popular and widespread dosage form. While oral treatment for ED is easy and painless, it may lead to significant potential side effects (headache, dyspepsia, rhinitis, visual disturbances, etc.). It is also slower-acting than injection or intraurethral therapy, is not ideal for individuals with dysphagia, and can be troublesome for those with allergies or dietary restrictions⁴.

Compounded dosage forms for the treatment of ED

Pharmaceutical compounding enables access to personalized healthcare solutions prescribed by physicians, providing patients with flexible, effective, and customized treatments for managing ED.

Developing patient-tailored dosage forms for the management of ED can provide noninvasive, accurate, and potentially easy-to-use delivery systems, which, as a result, may also improve patient compliance. Some examples of currently-used dosage forms, in addition to the dosage forms mentioned above, include:

Oral transmucosal films

NovaFilm^TM oral transmucosal films (OTFs) are an emerging and novel dosage form in compounding, which has also been used as a delivery vehicle for ED medications. They are applied as a thin layer to the oral cavity and dissolve in less than a minute, releasing the API through the oral mucosa⁵.  

Rapid-dissolve tablets (RDTs)

These fast-disintegrating, sublingual tablets disperse quickly in the mouth before swallowing, leading to rapid medication absorption and a quicker onset of action⁶. One example of this dosage form is the Medi-RDT™ Base, which is lactose- and sugar-free and compatible with a wide range of active ingredients.

For dosage forms with limited deliverable capacity, like RDTs and OTFs, flavoring agents like menthol are typically added to formulations.

Capsules

Capsules are a useful dosage form for treating ED paired with a suitable base. They can contain multiple APIs and be personalized to accommodate patient-specific dietary restrictions better.

They are easy to use and painless. However, they are also typically slower-acting than local injections and may have more limited bioavailability.

Troches

Troches can also be used to treat ED. These lozenges are a sublingual dosage form made with a troche base that dissolves in the mouth, bypassing the first-pass metabolism and potentially leading to a quicker onset than a pill or capsule.

Injections

Injections can be an effective dosage form for many men who do not respond to oral ED medications or have conditions that contraindicate their use. Like capsules, they can carry multiple APIs to accommodate more treatment options and are relatively fast-acting dosage forms.

Topicals

Locally applied agents in a cream or gel base can also help promote penile blood flow. Topicals serve as an alternative to more invasive forms of therapy and can be used in patients for whom the use of oral PDE-5 inhibitors is contraindicated or not well tolerated⁷.

However, topicals can have adverse effects due to their direct application (genital burning, inflammation, itching, etc.) and may be less efficacious than other dosage forms, such as local injections.

While ED can significantly impact a patient’s psychological and personal well-being, multiple steps can be taken to minimize and manage the condition. By adjusting dosage forms, combining multiple APIs, and excluding certain ingredients, physicians can prescribe patients personalized healthcare solutions suited to their needs.

For more information on current options for the management of ED, watch the free webinar from our partners in Education at LP3 Network,* or explore the Medisca formula library.

This information is presented for educational purposes only and does not suggest or endorse any treatment option. In all cases, the patient is advised to consult with their healthcare professional to determine the most appropriate treatment.

*LP3 Network is a separate educational provider that develops and markets educational programs in the compounding area. Medisca makes no recommendation and takes no responsibility for the contents of any LP3 Network offerings. In all events, the consumer is advised to consult with their healthcare professional regarding therapeutic options and treatment of any medical condition.

1. Mullhall, J.P. (2002). Sublingual apomorphine for the treatment of erectile dysfunction. Expert Opinion on Investigational Drugs, 11(2), 295-304.
2. Preckshot, J. (1999). Male impotence and the compounding pharmacist. International Journal of Pharmaceutical Compounding, 3(2), 80-83
3. Droggrell, S.A. (2005). Comparison of clinical trials with sildenafil, vardenafil, and tadalafil in erectile dysfunction. Expert Opinions in Pharmacotherapy, 6(1), 75-84.
4. Huang, S. A., & Lie, J. D. (2013). Phosphodiesterase-5 (PDE5) Inhibitors in the Management of Erectile Dysfunction. P & T: a peer-reviewed journal for formulary management, 38(7), 407–419.
5. Dadey E. (2017). Bioequivalence of 2 Formulations of Sildenafil Oral Soluble Film 100 mg and Sildenafil Citrate (Viagra) 100 mg Oral Tablets in Healthy Male Volunteers. American Journal of Therapeutics, 24(4), e373–e380.
6. Deveci, et al. (2004). Sublingual sildenafil in the treatment of erectile dysfunction: faster onset of action with less dose. International Journal of Urology, 11, 989-992.
7. Schanz, S., et al. (2009). Topical treatment of erectile dysfunction with prostaglandin E₁ ethyl ester. Journal of the German Society of Dermatology, 7, 1055-1059.