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Frequently Asked Questions
Esomeprazole is the S-isomer of omeprazole and provides more consistent acid suppression than Pantoprazole due to its higher bioavailability and slower metabolic clearance. Esomeprazole achieves faster onset of acid inhibition and maintains intragastric pH above 4 for longer durations, which is clinically important for healing erosive esophagitis. Pantoprazole, while slightly less potent, has a more predictable pharmacokinetic profile, fewer drug-drug interactions via CYP450, and is available in both oral and intravenous formulations, making it versatile for hospital and outpatient use.
Domperidone is a peripheral dopamine D2 receptor antagonist that enhances gastric motility by increasing lower esophageal sphincter pressure, improving antroduodenal coordination, and accelerating gastric emptying. Unlike metoclopramide, Domperidone does not readily cross the blood-brain barrier, significantly reducing the risk of central nervous system side effects such as extrapyramidal reactions and tardive dyskinesia. This makes it particularly suitable for long-term management of diabetic gastroparesis, functional dyspepsia, and chronic gastroesophageal reflux disease.
For proton pump inhibitor APIs like Esomeprazole and Pantoprazole, we offer dissolution testing in multiple media including pH 1.2 simulated gastric fluid, pH 4.5 acetate buffer, and pH 6.8 simulated intestinal fluid, both with and without surfactants. Since PPIs are acid-labile, we conduct dissolution testing in biorelevant media and can supply APIs with defined release profiles for immediate-release or delayed-release (enteric-coated) formulations. Dissolution profiles are compared using f1 and f2 similarity factors to ensure batch-to-batch consistency.
Yes, we can supply antacid APIs like Magnesium Hydroxide and Dried Aluminum Hydroxide with specified acid-neutralizing capacity (ANC) profiles. ANC is measured according to USP method, representing the milliequivalents of acid neutralized per gram of antacid. We can supply grades with ANC values ranging from 20-30 mEq/g for Magnesium Hydroxide and 5-10 mEq/g for Dried Aluminum Hydroxide. We also control physical properties like surface area, porosity, and particle size that influence the rate and duration of acid neutralization, allowing formulation of fast-acting or sustained antacid products.
We provide comprehensive regulatory support for gastrointestinal product registrations globally. For PPIs, we can supply CEP (Certificate of Suitability to the European Pharmacopoeia) where applicable, which simplifies the review process for EMA filings. For the US market, we prepare and maintain Type II DMFs with periodic updates. We also provide stability data to support retest periods, impurity qualification data according to ICH Q3A/B, elemental impurities assessment per ICH Q3D, and nitrosamine risk evaluations as per recent EMA/FDA guidance. Our regulatory team can also assist with responding to authority queries during dossier review.
