Not all thyroid conditions are the same. Not all patients are the same. As a healthcare provider you know this all too well. When it comes to thyroid balance, too much or too little, and everything is thrown off – changes in mood, weight, and energy level are just some of the many symptoms. The complexity and crossover effect of thyroid function, as well as individual set points, lead to differences in clinical expression – and the challenging part – differences in response to therapeutics.
While commercial medications for the treatment of thyroid imbalance exist, fixed dosing increments and forms, unwanted ingredients, and commercial unavailability may impose limitations for healthcare providers that may result in unmet needs for their patients. With these challenges, providers are tasked to think outside the box – something we know compounders do on the daily. In this blog we will explore compounding options for managing thyroid insufficiency when commercially available products are unavailable or unsuitable to meet patient needs. Let’s break it down.
When commercially available products are unavailable or unsuitable to meet patient needs, alternative measures, such as compounding may be required. Defined as the practice of preparing customized compounded medications in accordance with a licensed practitioner’s prescription to address a patient’s unique set of conditions, tolerances, and preferences, pharmaceutical compounding allows providers to consider the following for thyroid treatment plans:
Dosing is based on an individual’s age, height, weight, cardiovascular status, concomitant medications, and severity of thyroid imbalance. With so many factors at play, pharmaceutical compounding provides the flexibility to prescribe various dosage strengths and dosage forms that are suitable in meeting the patient’s specific needs.
It is known that lactose, an excipient found in many thyroid preparations, may affect absorption of thyroid drugs and may contribute to patient intolerance2
. Gluten, aluminum, and colorants may have similar effects and are also of concern. Compounded thyroid preparations can be made free of unsuitable fillers that may impede drug absorption or impact patient tolerance.
Part of the pharmaceutical compounding process includes considering alternative dosage forms. At present, thyroid medications are generally commercially available in oral tablet and capsule form3
. Other options may include oral liquids for patients unable to swallow tablets/capsules and sublingual forms for patients with refractory hypothyroidism that may be caused by gastric absorption4,5
Levothyroxine (L-T4) is the gold standard for hypothyroid treatment and one of the most commonly prescribed drugs in America6
. However, approximately 5-10% of the population continue to have symptoms despite normal TSH and T4 levels7
. A hypothesis for this symptom prevalence includes individual differences in the ability to convert L-T4 to its active form, liothyronine (T3), leaving these individuals limited in their ability to achieve therapeutically effective levels. Indeed, genetic differences and age are known to impact this conversion8,9
. Taken together, for certain individuals, L-T4 alone may not be able to achieve the desired outcome, creating a rationale for L-T3 supplementation8
Further contributing to the discussion around combination therapy is the growing evidence supporting patient preference for combination L-T4 + L-T3 therapy. In a 2018 survey of more than 12,000 people with hypothyroidism, desiccated thyroid extract – a naturally derived source of L-T4/L-T3 – was preferred over LT-4 alone10
. Although not currently considered by the American Thyroid Association as a first-line treatment option, certain patients may benefit from this therapeutic alternative1
. Interestingly, in a 2017 survey of American Thyroid Association members, it was discovered that combination therapy is becoming more commonly prescribed by North American physicians11
When considering combination L-T4 and L-T3 therapy, providers have the following options available to them:
- Commercially available L-T4 alone + commercially available L-T3 alone. At present, L-T4 and L-T3 are only commercially available as separate medications that would need to be taken independently. While this can be a suitable option for some patients, it can be challenging for others to maintain leading to poor compliance.
- Compounded L-T4 and L-T3 combination. Simplifying the treatment regimen, L-T4 and L-T3 can be combined into a single dosage form at the desired strength and ratio. Excipient ingredient and dosage form selection can also be tailored when preparing the compounded medication.
- Commercially available desiccated thyroid extract. Desiccated thyroid extract or DTE is a natural source of combination T4 and T3 that is available in a variety of strengths. The challenge with this medication is the frequent recalls due to inconsistent potency12. Furthermore, certain commercial forms of DTE contain excipients that may interfere with absorption and impact patient tolerance.
- Compounded desiccated thyroid extract. Compounded DTE can be considered when commercial products are unavailable, when dosage strength or form need to be tailored, or when certain ingredients need to be avoided.
Having the right tools to compound thyroid is an important part of the overall planning process when establishing personalized medications for patient-specific needs. From quality premade bases to reliable compounding equipment, and formulation support – all are vital pieces to the puzzle.
For capsules, Medisca CapsuBlend®-S
is an ideal option. A premixed excipient blend, this base is recommended for highly soluble active ingredients, such as Thyroid, USP, and features improved drug dissolution13
. This base is free of lactose, corn, and gluten.
For rapid dissolve tablets, Medisca Medi-RDT™ Base
is a finely granulated powder that is compatible with a wide range of active ingredients. It has a significantly faster wetting time (5 seconds) and disintegrating time (93 seconds) compared to similar products on the market, and is free of preservatives, dyes, sugar, lactose, and gluten.
For liquid compounding, Medisca Oral Mix
is an alcohol and dye-free vehicle that brings together the suspending properties of Medisca Oral Suspend and the cherry flavoring properties of Medisca Oral Syrup. A one-step vehicle that helps deliver elegant, flavourful, and physically stable suspensions.
Don’t do it alone. Day-to-day Compounding Service Support
is available – everything from access to an online formula databank, to daily compounding support with our team of Compounding Service experts, and clinical consultation support with our subject matter experts.