What formulators 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗸𝗻𝗼𝘄 about tablet design?
---
Before you start designing your new product, you should know the initial safe starting dose, the maximum tolerated dose, and evaluate how wide the range is between these two values.
Now lets design a tablet.
If the MTD is relatively high, you should first check your options for size and shape. Large doses = large tablet (usually). Also, issues with patient adherence to a treatment schedule.
So, consider this during early product development even when the clinical studies being performed in are well-controlled using healthy volunteers. Also, your marketing group is usually not involved at this stage. Ask any marketer how easy it is to promote a horse pill.
Ok, on to some useful info.
To establish the tablet weight of a new product, you need to consider some factors and perform some calculations.
First, determine the true density of your powder blend, This is a value that represents the density of the solid material without any air spaces.
Next, decide on the desired tablet dimensions, including the diameter and thickness. These dimensions will help you calculate the volume of the tablet.
Almost there.
You can calculate the theoretical weight of a fully dense tablet by multiplying the volume by the true density. However, tablets are not fully dense, so you'll need to account for the solids fraction.
The solids fraction refers to the proportion of a mixture's total volume that is occupied by solid particles. It is expressed as a decimal or percentage ranging from 0 to 1 (or 0% to 100%).
Now you can calculate the target tablet weight as follows:
Target Weight = Solids Fraction (decimal) x Density (weight/volume) x Volume (volume)
Keep in mind that this calculated value is theoretical, and you'll need to perform trial compressions to fine-tune the actual tablet weight. Factors such as powder flowability, compressibility, and the specific formulation can affect the final tablet weight. Additionally, you may need to adjust the weight to achieve desired hardness, disintegration time, or dissolution profile.
Now, compare the tablet weight at the MTD to the tablet weight at the initial starting dose. Does the formulation scale? Can you maintain proportionality or do you need a dose-similar design, or something else entirely?
Last thing: just like different blends will have different true densities, different tablet shapes will have different volumes. Using these variables, you can experiment to see what works best for you.
#pharmaceuticals #formulation
---
If you found this interesting or helpful, consider reposting ♻️, follow me, and click the 🔔 so you don't miss future content.
