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Work is way better when you've got a good team 🤜🤛 Meet Lori Desai She's Sharp Clinical's Manager of Validation Engineering, and she recently took some time out to sit down with me and talk all about some of the special projects we have going on at Sharp. Look for that to come out soon. Validation vibes 😎 Excited to work alongside this awesome manager and the entire #validation #team. --- This series hopes to show all of the talented people that work to bring your product to life. If you know someone who's doing amazing work that you want to see featured, tag them in the comments below.

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.

The Sharp UK team representing the site at Business Fives event in Cardiff today. Very proud of them all. Best of luck all. Bring home the cup - even if it is a plastic one :) Sharp Services - Just need a photo of our skipper: Ian Holton

3 notes I took from FDA's new Dose Optimization Guidance 📓 --- Instead of simply seeking the maximum tolerated dose, this new guidance recommends optimizing the dosage of human prescription drugs and biological products used to treat oncologic diseases to find a dose that maximizes therapeutic benefits while minimizing toxicity. The guidance encourages sponsors to consider multiple dosages in clinical trials and engage in early discussions with the FDA to ensure that the approved dosage provides the best possible outcomes for patients. The drug formulation section emphasizes: 1. 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝘂𝗹𝘁𝗶𝗽𝗹𝗲 𝗗𝗼𝘀𝗮𝗴𝗲𝘀: Planning for various dose strengths allows for a comprehensive evaluation of a drug's efficacy and safety across a range of dosages. This is essential in identifying the optimal dose. No excuses granted for manufacturing difficulty in achieving this. 2. 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀: For oral formulations, the size and number of tablets or capsules are factors that can influence patient adherence to treatment. If a dose requires an impractically large number of pills or excessively large tablets, patients may struggle to comply with their regimen. Ensuring that the final dosage form is appropriate for the intended patient population enhances the likelihood of adherence and, consequently, the overall effectiveness of the treatment. 3. 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗘𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗶𝗻 𝗣𝗮𝗿𝗲𝗻𝘁𝗲𝗿𝗮𝗹 𝗙𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀: When it comes to parenteral formulations, the final concentration and volume to be administered are vital for ensuring both safety and efficacy. Appropriate concentrations help achieve the desired therapeutic effect without causing toxicity or adverse reactions. Additionally, the volume must be manageable for the patient, as excessively large volumes can lead to discomfort or complications. Link to the guidance is here for your own reading . https://lnkd.in/evwMVRAd And if you're looking for clinical trial supplies for your next study, did you know that Sharp has formulation development, GMP manufacturing and packaging suites, QC release testing, and logistics and supply chain management solutions all under one roof? Send me a message to learn more! #pharmaceuticals #FDA #clinicalresearch