Inertness
Compritol® 888 ATO is inert
Compritol® 888 ATO – glyceryl dibehenate – does not react with active pharmaceutical ingredients (API) or other excipients.
Its inertness is explained by its chemical nature and Gattefossé’s robust production process:
- It is a lipid excipient with less than 1% of water
- It does not have reactive groups
- It has very low level of impurity: low peroxide value, low iodine value
Precedence of use
More than 50 years of use around the world in tablets is proof that Compritol® 888 ATO is a high performance
lubricant.
Glyceryl dibehenate has been successfully used with the following APIs:
Aceclofenac, Acetaminophen, Acetylsalicylic acid, Adefovir dipivoxil, Ademetionine, Alfuzosin, Aluminium phosphate, Amlodipine, Amlodipine besylate, Amoxicillin, Ascorbic acid, Atorvastatin, Benzalkonium chloride, Benzocaine, Bexagliflozin, Bismuth subgallate, Bisoprolol, Bosentan, Bosentan hydrate, Brensocatib, Bromelain, Bupropion, Cefprozil, Chlophenamine, Chlorpheniramine, Chlorpheniramine maleate, Chondroitin sulfate, Clarithromycin, Clemastine, Clopidogrel*, Crizotinib, Dehydrocholic acid, Dequalinium, Dextromethorphan, Diclofenac, Diclofenac potassium, Diltiazem, Diphenhydramine, Diphenhydramine citrate, Diphenidol, Domperidone, Ecabet sodium, Eliglustat, Emodepside, Enalapril, Entacapone, Escitalopram, Esomeprazole, Estriol, Famotidine, Felodipine, Fesoterodine, Fosinopril*, Fosinopril sodium*, Gabapentin, Gliclazide, Glipizide, Glucosamine, Hydrochlorothiazide, Hydrocodone, Hydrocortisone acetate, Ibuprofen*, Iron, Lansoprazole, Levofloxacin, Levofloxacin hemihydrate, Loperamide, Lysozyme, Magnesium hydroxide, Magnesium salts, Mazindol, Meloxicam, Metformin, Methazolamide, Methyl-sulfonyl-methane, Montelukast, Mosapride citrat hydrate, Naftidrofuryl, Naftidrofuryl oxalate, Nicotinic acid, Omeprazole, Orlistat, Pancreatin, Phenylephrine, Plant extracts, Polycarbophil calcium, Prasugrel, Prasugrel hydrochloride, Proglumetacin, Pseudoephedrine, Ramipril, Ranitidine, Rasagiline hemitartrate, Rifamycin, Rilmenidine, Roxithromycin, Sevelamer carbonate, Simethicone, Siponimod fumarate, Sirolimus, Sodium picosulfate, Tegaserod, Tegaserod maleate, Theophylline, Thioctic acid, Ticlopidine, Tilidine, Toltrazuril, Tranexamic acid, Trimebutine, Tropicamide, Valsartan, Vitamins, Zileuton (non exhaustive list).
*API incompatible with magnesium stearate
Robustness
Compritol® 888 ATO is insensitive to mixing conditions
Mixing time and speed do not impact Compritol® 888 ATO lubricant efficiency nor tablet hardness, irrespective of its concentration.
Compritol® 888 ATO facilitates scale-up
Case studies showed that with Compritol® 888 ATO
- Excellent batch reproducibility is obtained
- Press speed has no impact on tablet properties
- No difference observed between lab and pilot scale
Conditions of use
Level of use: 1 to 3%.
Recommended process for an R&D batch:
Quality by Design
Quality by Design aims to understand the variation of excipient properties related to Critical Process Parameters (CPP) and Critical Quality Attributes (CQA), to ensure more robustness and flexibility in the manufacturing process and enhance drug product quality.
Gattefossé supports customer’s QbD programs by providing data on Compritol® 888 ATO to facilitate the establishment of the final product Critical Quality Attributes (CQA).
Efficiency
Compritol® 888 ATO: an efficient lubricant for tablets
Frictions are efficiently reduced
Transmission ratio R is the ratio between upper punch and lower punch forces. If friction is high, ratio R decreases. A good lubricant will give an R value near 1. Ejection force is the force necessary for the lower punch to eject the tablet from the die. The lower the ejection force, the better the anti-friction effect of the lubricant.
Sticking is effectively avoided
Residual pressure on the upper punch of the tableting machine is measured. If the tablet sticks to the upper punch, residual pressure will be high.
Compritol® 888 ATO maintains tablets properties
During mixing, the lubricant particles form a hydrophobic film at the tablet surface. With common lubricants this can sometimes adversely impact tablet hardness, disintegration time or drug release. With Compritol® 888 ATO the tablet properties (hardness, disintegration time or drug release) are maintained.
For further information
A complete technical file is available from your local representative or contact via www.gattefosse.com. This document compiles latest data available on Compritol® 888 ATO as a lubricant for pharmaceutical tablets, based on main scientific publications and Gattefossé’s case studies
Two grades for pharmaceutical tablets
Compritol® 888 ATO and Compritol® HD 5 ATO
