Although solid dosage forms like tablets and capsules continue to dominate the global pharmaceutical market, many people find them challenging to take. There is evidence to suggest that oral liquid dosage forms may offer untapped opportunities, with the potential to:
- improve patient experiences and compliance
- reduce healthcare costs
- create new revenue streams.
In a study conducted by Spiegel Institut Mannheim for Hermes Pharma, 2,000 people in the United States and Germany were surveyed about their experiences and preferences with tablets and capsules compared to other dosage formats. According to the results, difficulties swallowing solid dosage forms are a widespread issue that may be impacting the success of treatment.
More than half of all respondents (50% in the US and 60% in Germany) reported difficulty swallowing tablets or capsules, with about a third saying that it was a serious problem. Tablet size was a common challenge for people of all ages, though taste and odor also played a role, especially among younger respondents (age 16–34). There
have been many attempts to overcome these difficulties, such as breaking tablets, crushing and dissolving them in water, or chewing them, but they all can have a negative impact on the medication’s effectiveness. Worse, 8% indicated that these challenges discouraged them from taking their medication at all.
The study concluded that more user-friendly dosage forms better meet consumer needs, especially if they smell and taste appealing, and could potentially be more successful than traditional solid forms.
Multiple Business Cases For Oral Liquid Dosage Forms
Distaste for the size, flavor, and smell of solid drugs aren’t the only factors driving renewed interest in alternatives like oral solutions, suspensions and syrups. These formulations have much to offer in a variety of pharma scenarios, including:
- Pediatrics —Liquid formats have historically been one of the most common oral dosage forms for children. This is in part because they are easier to swallow — an issue for around 70% of younger participants in the study cited above. Another factor is that younger children are often unable or unwilling to use chewable tablets. Liquids also offer the flexibility to adjust dosage to a level appropriate to the child’s current weight.
- Early Phase Formulations —Liquid formulations are frequently used in first-in-human trials. Even though it may not be possible to commercialize these “prototype” formulations, they have the advantage of being inexpensive, and flexible enough to meet the needs of Phase I clinical trials. As noted by Contract Pharma, however, a growing body of opinion suggests more attention should be paid to stability and bioavailability in such formulations, both to maximize the effectiveness of R&D and to streamline later development phases.
- Extending Patent Protection — Another conclusion of the Hermes study was that reformulating established medicines into alternative dosage forms can safeguard the investments of pharma companies by providing stronger IP protection, creating more product offerings to meet the needs of different consumers, and providing additional differentiation from competitors.
In the last year, the COVID-19 virus has also driven a significant increase in inquiries about oral liquid and suspension formulations, especially cough syrups.
Overcoming Liquid Dosage Challenges
Oral liquid formulations are not without their own difficulties. They have a reputation for unpleasant taste, are more cumbersome to transport than tablets or capsules (especially for children who need to take medications at school) and require more attention to ensure stability over time. These problems can frequently be solved with formulation adjustments or process improvements.
For example, a recent LGM Pharma client was experiencing difficulty with a pyrantel pamoate formulation. It had issues with both its suspension properties and its manufacturing process. This product has been on the market for many years, and the formulation was receiving complaints from customers because of its tendency to “cake,” or form clumps of material. This presented a significant obstacle to scaling up production. In addition, the product had recently changed API providers, and the new API was found to be too viscous.
Upon examining the product, LGM discovered that the caking was the result of insufficient suspension properties. We quickly solved the API challenge by adjusting the formulation and introducing a two-kettle manufacturing process. As a result, the client was able to scale up production of the product by almost four times the original quantity produced.
In another case, while working on a hydrocodone bitartrate and homatropine methylbromide syrup formulation, the co-solvent turned out to be incompatible with the syrup formula. Working with one of our vendors, LGM created a low-flavor substance that introduced the co-solvent into the formulation without interfering with the original formula and taste.
These are just two examples of the many types of liquid dosage challenges LGM can solve – whether you are working with a solution, syrup or suspension. Contact us for more details or to discuss any specific challenges your organization may be facing.