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Modified-Release Delivery Systems
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Frequently used materials for enteric coating are polymeric acids with free carboxyl groups that confer gastric resistance. They include anionic polymethacrylates (copolymerisate of methacrylic acid: methylmethacrylate or ethyl acrylate, Eudragit L 30 D-55, Eudragit FS 30 D, or Eudragit-L100, with a pH value of aqueous dispersion of ~3.05) and cellulose-based polymers (i.e., hypromellose acetate succinate [HPMCAS], with pH about 3.85) or hypromellose phthalate (HPMCP), aqueous cellulose acetate phthalate (Aquateric), or polyvinyl derivatives such as polyvinyl acetate phthalate (Coateric). Since aqueous dispersions of Eudragit L 100 have high film-forming temperatures of about 85°C, mixing with the softer Eudragit L 30 D 55 makes it possible to reduce the film-forming temperature to about 40°C, which is a more acceptable range especially when hard gelatin capsules and HPMC capsules are coated. For modulation of drug release in pH 5.5 to 7.0, further mixing with Eudragit NE 30 D and FS 30 D is an acceptable option. Explicitly aqueous dispersions for enteric coating (Eudragit L 30 D-55) and colonic coating (Eudragit FS 30 D) of HPMC and hard shell gelatin capsules have been investigated.31,32 Apart from enteric film formers, other enteric film coating components include plasticizers (i.e., diethyl phthalate, triacetin), anti-adhesion agents, colorants, pigments, solubilizers, and dispersing agents. To these may be added viscosity-enhancing suspension stabilizers designed to retard the sedimentation of undissolved excipients or dispersed film formers.
The safety of phthalate-containing medications used during pregnancy
Published in Expert Opinion on Drug Safety, 2023
Amaan Ali, Jan Stener Jørgensen, Ronald F Lamont
We carried out a search based on ‘the Safety of phthalate-containing medication use during pregnancy’ using the following keywords/MeSH terms on Pubmed/MEDLINE: (safety) OR (preterm birth) OR (mortality) OR (preeclampsia) OR (morbidity) OR (outcome) OR (small for gestational age) OR (prematurity) OR (birth defects) OR (miscarriage) OR (stillbirth) OR (complication) AND (pregnancy) AND (phthalate) OR (diethyl phthalate) OR (dibutyl phthalate) OR (hypromellose phthalate) OR (cellulose acetate phthalate) OR (polyvinyl acetate phthalate). Our database search yielded 765 papers. After application of the following exclusion criteria, the number of relevant papers was reduced to 104: duplicate studies, no exposure to phthalates, review articles, case reports, not in English, no full text available, no patient outcomes provided and non-human studies. The most relevant papers from this search relating to phthalate exposure and pregnancy outcomes were selected.
Use of phthalate-containing prescription drugs and the risk of gastric cancer: a Danish nationwide case-control study
Published in Acta Oncologica, 2019
Zandra Nymand Ennis, Sidsel Arnspang Pedersen, Morten Rix Hansen, Anton Pottegård, Thomas Patrick Ahern, Jesper Hallas, Per Damkier
From the National Prescription Registry, we had information on all prescriptions redeemed by all Danish citizens from 1995 onwards. The database maintained by the Danish Medicines Agency provided detailed information on phthalate content per tablet or pill, in drug-products in Denmark from 2004 onwards. We defined exposure by the cumulative amount of ortho-phthalates or enteric phthalate polymers filled via prescription medicine during the period 2004–2015. This was done by linking information on package size and phthalate amount per tablet or pill for all dispensed prescriptions by all subjects included. Ortho-phthalate exposure was characterized by specific phthalates: DEP and DBP. Likewise, enteric phthalate polymers were characterized by specific compounds: cellulose acetate phthalate (CAP), hydroxypropylmethylcellulose phthalate (HPMCP) and polyvinyl acetate phthalate (PVAP).
Development of a new esomeprazole delayed release gastro-resistant pellet formulation with improved storage stability
Published in Drug Development and Industrial Pharmacy, 2018
Panagiotis Barmpalexis, Agni Grypioti
There are several enteric coating polymers used as protecting agents against gastric fluids. Common examples include synthetic polymers such as polymethacrylates, cellulose acetate phthalate (CAp), hypromellose phthalate (HPMCp), and polyvinyl acetate phthalate (PVAp) [16,17]. All these polymers exhibit pH-dependent solubility, with increased solubility at pH values above 5.0 (intestinal fluids) and restricted solubility at lower pH values (gastric fluids). Hence, when the enteric-coated formulations are administrated orally, the API does not release until it reaches either the small (duodenum) or the large intestine area, where it is chemically stable. However, it is important to note that, although the usage of enteric coating polymers protects the PPIs from the acids of the stomach, and hence improves API’s in vivo stability and bioavailability, the direct contact of a PPI with the enteric-coating polymer (which is also, in many cases, an acid itself) causes important storage stability problems. Hence, in order to overcome this incompatibility between the API and the enteric-coating polymer(s), sub (or seal)-coating layers, working as protective barriers between the PPI and the enteric polymer, are usually employed.