While tablets offer a wide range of benefits for the manufacturer and end-user, the FDA had initial concerns about different tablet shapes and sizes affecting patient compliance, acceptability, and medication errors. Thomas Processing explains how different pharmaceutical tablet shapes and sizes affect end users.
- Tablets offer a variety of benefits over other dosage forms.
- About 16 million people in the U.S. have some difficulty swallowing tablets and capsules.
- Flat tablets offer improved esophagus tolerance compared to capsules.
- Studies show that oval tablets may be easier to swallow and provide a faster esophageal transit time than round tablets.
- There are a variety of patient factors that affect a person’s ability to swallow tablets or capsules.
- Tablet shape and size affect a patient’s ability to swallow tablets and capsules.
- Tablet coating can improve swallowing tablets and capsules.
If they’re the right shape and size, tablets provide a variety of benefits over other dosage forms:
- Seamless storage
- Easy administration
- Dosage accuracy
A guidance report was created by the FDA to ensure that regulatory requirements are met and align with patient safety based on tablet shape and size.
According to the report, about 16 million people in the U.S. have some difficulty swallowing, a condition also known as dysphagia. Dysphagia could make it difficult to swallow tablets or capsules, and could lead the person with the condition to skip doses or discontinue treatment.
Certain tablet shapes are easier to swallow than others. Flat tablets offer improved esophagus tolerance compared to capsules, according to the report. Studies show that oval tablets may be easier to swallow and provide a faster esophageal transit time than round tablets. The tablet’s size and shape may also influence patient compliance with the medication regimens.
There are a variety of patient factors that affect a person’s ability to swallow tablets or capsules:
- Body position
- Fluid intake
- Medical conditions
While all patient factors can’t be addressed with design and manufacturing solutions, developing tablets and capsules with size and shape in mind can help certain patients swallow more easily. Designing and manufacturing smaller tablets and capsules can minimize swallowing challenges and improve patient compliance with medication regimens. The FDA recommends that tablet manufacturers design and develop their products with patient factors in mind.
The tablet coating process can also improve swallowing tablets and capsules. Studies show that uncoated tablets can decrease or prevent tablet mobility compared to film-coated tablets of the same size and shape. The tablet coating process can also improve other factors that affect patient acceptance, like taste, color, and smell.
The following recommendations presented by the FDA should be followed when manufacturing different sizes of pharmaceutical tablets or capsules in generic form to align as closely as possible with its reference listed drug (RLD):
- If the RLD is less than 17 mm in its largest dimension, the generic tablet or capsule should be:
- No more than 20% larger than the RLD in a single dimension and shouldn’t exceed 17 mm
- If the RLD is equivalent to or more than 17 mm in its largest dimension, the generic tablet or capsule should be:
- No larger than the RLD in any dimension
- No more than the volume of the RLD
Tablets and capsules that are 8 mm or smaller in their larger dimensions are typically given more flexibility, but manufacturing generic products similar in size to the RLD should always be the goal.
The FDA states that manufacturing tablets and capsules in round or flat shapes makes them easier to swallow than others like squares and rectangles.
When selecting and manufacturing the shape of generic tablets or capsules, evaluate and compare the largest cross-sectional RLD areas to the generic product to measure shape changes.
Other tablet and capsule physical characteristics to improve swallowing include consistent tablet coating, weight, surface area, disintegration time, and swelling propensity.
There are a lot of factors to consider when selecting a pharmaceutical tablet shape. But with Thomas as your coating expert, you can leave the analysis up to us. We have experience coating a variety of tablet shapes and sizes and have processes in place to scan for dozens of coating problems as they arise. Contact us today to learn more about how we can help you find the right tablet coating machine for your unique tablet size and shape needs.