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Hard Shell Capsules in Clinical Trials
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Moji Christianah Adeyeye, Amusa Adebayo
Eudragit S and Eudragit NE at a 3:7 ratio was reportedly used by several authors [87–89] to coat formaldehyde-treated hard gelatin capsules filled with a gelled insulin microemulsion. The system was pH-dependent based on the composition of the coat. Cellulose acetate phthalate was used to provide gastro-resistance. The colon-targeted capsules, administered to dogs, showed significantly greater pharmacological availability in comparison with a non-encapsulated liquid insulin microemulsion and an insulin-free colon-targeted capsule. The potential for utilization of the delivery system is high for oral delivery of peptides and proteins.
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).
Targeting the intestinal lymphatic system: a versatile path for enhanced oral bioavailability of drugs
Published in Expert Opinion on Drug Delivery, 2018
Renuka Suresh Managuli, Sushil Yadaorao Raut, Meka Sreenivasa Reddy, Srinivas Mutalik
A major factor which determines the efficacy of any nanocarrier is its capability to incorporate the amount of drug in it. Entrapment efficiency must be greater in order to administer required therapeutic dose without affecting the safety and efficacy of the patients. In case of nanocarriers meant for oral administration, the foremost hurdle faced is the harsh acidic condition of gastric fluid in the stomach. Lipids are most susceptible for degradation in acidic pH of stomach [38]. pH sensitive polymers such as Eudragits, hydroxypropylmethylcellulose phthalate, cellulose acetate phthalate, etc. have been used in the nanocarrier fabrication to resist the drug release in stomach [157]. Direct enteric coating of nanoparticles has been reported in the literature to withstand the acidic condition of stomach [158–161]. However, the intactness of the nanocarriers in the alkaline pH condition of intestine after the dissolution of enteric coat has hardly been reported. As size is an important characteristic for the absorption into lymphatic system through Peyer’s patches, any kind of distortion in the size of the nanoparticle (especially soft nanoparticles such as NLCs) after the dissolution of enteric coat must be assessed. For enteric coating of the nanocarriers, most of the reported articles state the use of organic solvent to prepare enteric coating solution which is then added to nanoparticle dispersion [159,161]. However, lipids and polymers are susceptible to organic solvent creating difficulty in enteric coating and even the integrity of the nanoparticles during enteric coating is questionable. To eliminate such uncertainties in enteric coating of nanoparticles, enteric coated capsules containing nanoparticles can be administered.