I Can See Clearly Now: Compounding Ophthalmic Medications
Ophthalmologists and other medical professionals who work with eyes have a frequent need for compounded ophthalmic medications. In fact, a recent joint letter from the American Academy of Ophthalmology, the American Association for Pediatric Ophthalmology and Strabismus, the American Glaucoma Society, the American Society of Retina Specialists, and the Cornea Society stated the position that there is a crucial, ongoing need for compounding ophthalmic medications, and that the health of patients will suffer without them. The fact is, this is an important set of needs for compounding pharmaceutical providers to meet.
The Need for Compounded Ophthalmic Medications
Ophthalmic medications lend themselves to compounding for several reasons. One is simply a matter of concentration, dosage, and especially format; eyedrops are a common delivery method as are ointments, and both are very easily and effectively compounded.
Many kinds of ophthalmic medications can only be obtained through compounding. Not all patients can tolerate preservatives, so formulations of drugs that are preservative-free versions of commercially-available ophthalmic medications are a good example of this. Another example is combinations of drugs that cannot be obtained commercially, such as combination anesthetic and dilating agents, combination antimicrobial drops, and mixed allergy solutions.
In many treatment areas, availability of drugs has been far outpaced by demand. But, as described above, the specific needs of ophthalmic patients and the special considerations that exist concerning ocular agents mean that there is a major demand for specialty compounded ophthalmic medications for treatment of eye diseases.
Many commonly-used ophthalmic medications are either not commercially available or, despite widespread use, do not have FDA approval for ophthalmic use. There are many reasons why a drug may no longer be available, especially in the case of drugs for treating ocular disorders. Many products cannot be produced on a commercial scale because they don’t have a long shelf life or they lack stability. This is frequently the case for antibiotic ophthalmic medications; even compounded antibiotic ophthalmic medications — both injectable intraocular and topical varieties — that are compounded from commercially available preparations, only last a limited amount of time. Usually these must be kept no more than 14 days in temperature controlled conditions.
Some ophthalmic medications themselves, while fairly typical for use in the field, are “special needs” in a pharmaceutical sense. Some patients need brilliant blue G dye, which is not commercially available. Still other patients actually require compounding because their regimen is completely specific. For example, certain ophthalmic patients such as those with severe dry eye issues must have autologous serum eye drops that make use of their own serum.
Common Ophthalmic Medications
Patients with chronic dry eyes may require ointments or eye drops to decrease inflammation around the surface of the eyes. Treatments with autologous serum eye drops, mentioned above, work to solve the problem using the patient’s own serum. This helps the eye’s surface by providing the natural concentrations of growth factors and vitamins that are critical for good corneal epithelial health.
Delay in treating bacterial corneal ulcers or insufficiently strong treatment can have serious consequences in a short time, including corneal perforation and scarring, and even blindness. Compounded fortified topical antibiotics are therefore the preferred course of treatment. Topical fluoroquinolones gatifloxacin and moxifloxacin are common choices.
Fungal keratitis is particularly dangerous because it often develops rapidly and can result in blindness if left untreated. It is typically treated with antifungal agents, usually in eyedrops; these treatments are often most effective when customized. There are two kinds of antifungal agents used in ophthalmic medications: polyenes such as amphotericin B, natamycin, and nystatin, and azoles, imidazoles, and triazoles such as clotrimazole, econazole, fluconazole, itraconazole, ketoconazole, and miconazole. Amphotericin B is most often preferred for treating fungal keratitis patients whose infection is caused by yeasts. Fluconazole and ketoconazole are often used to treat deep fungal keratitis caused by filamentous fungi. All cases are vastly different since there are so many types of fungi. This is why compounding is so effective in this treatment area.
Styes might be treated with antibiotics such as Tobradex in eyedrops or ointments. Chalazia may sometimes benefit from treatment with any of a variety of anti-inflammatory treatments and topical steroids. When they do cause infections they can be treated with tetracyclines such as doxycycline and minocycline at higher doses which both fight the infection and reduce inflammation. In some cases, long-term low-dose tetracycline therapy may be indicated to prevent a recurring problem.
Obviously, ophthalmologists need reliable, skilled compounding providers with access to the best supplies and information. There will always be a need for compounded ophthalmic medications for a variety of applications, so this fascinating area will remain robust over time.
Compounding ophthalmic medications is an important specialty area that demands the highest degree of skill and quality. Fortunately, you have the ability to purchase your products and receive information from a reliable source. For more about pharmaceutical compounding and purchasing bulk APIs, please contact Pharmaceutica North America, your trusted compounding resource.