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The possible application of a hot-melt ram extrusion printing to the preparation of diclofenac orodispersible films (ODF) made of maltodextrin was studied focusing the attention on the effects of taste-masking agents (i.e. namely mint, licorice-mint, and sucralose) and an opacifier (titanium dioxide [TiO2]). This is a proof-of-concept of the feasibility to print ODF loaded with a thermosensitive drug substance by hot-melt technologies. Diclofenac sodium (DNa) ODF made of maltodextrin (dextrose equivalent (DE) = 6) plasticized with glycerol were prepared by hot-melt extrusion printing. ODF were characterized for disintegration time, drug content, and solid state, in vitro dissolution in deionized water and simulated salivary fluid at pH 5.7, tensile, and adhesive properties. Moreover, the stability of ODF was assessed in accelerated conditions over six months. After the preparation, no variation in drug solid state was evident and the formation of impurity A of DNa was detected, even if it remained below the Pharmacopoeia (Ph. Eur.) limits (< 0.2%). Only the addition of DNa significantly improved the ODF tensile properties: the tensile strength increased from 0.17 ± 0.03 MPa (placebo ODF) to 2.21 ± 0.54 MPa (p ≤ 0.03). All ODF disintegrated in about 1 min, and the t80% was lower than 3 min. TiO2 reduced the static and dynamic peel forces (p ≤ 0.006) favoring the ODF detachment from the primary packaging material. During the accelerated stability study, ODF were easy to handle without fracture; the drug content, impurity A, and dissolution profiles remained superimposable. Hot-melt printing can be suitable to prepare palatable ODF loaded with bitter thermosensitive drugs. [ABSTRACT FROM AUTHOR]

Digestible maltodextrins are low-sweet saccharide polymers consisting of D-glucose units linked primarily linearly with alpha-1,4 bonds, but can also have a branched structure through alpha-1,6 bonds. Often, maltodextrins are classified by the amount of reducing sugars present relative to the total carbohydrate content; between 3 and 20 percent in the case of digestible maltodextrins. These relatively small polymers are used as food ingredients derived by hydrolysis from crops naturally rich in starch. Through advances in production technology, the application possibilities in food products have improved during the last 20 years. However, since glucose from digested maltodextrins is rapidly absorbed in the small intestine, the increased use has raised questions about potential effects on metabolism and health. Therefore, up-to-date knowledge concerning production, digestion, absorption, and metabolism of maltodextrins, including potential effects on health, were reviewed. Exchanging unprocessed starch with maltodextrins may lead to an increased glycemic load and therefore post meal glycaemia, which are viewed as less desirable for health. Apart from beneficial food technological properties, its use should accordingly also be viewed in light of this. Finally, this review reflects on regulatory aspects, which differ significantly in Europe and the United States, and, therefore, have implications for communication and marketing. [ABSTRACT FROM PUBLISHER]

Background: Adhesive small bowel obstruction (ASBO) is an important cause of hospital admission, is associated with significant morbidity and mortality, and therefore is a substantial burden for healthcare systems worldwide. Icodextrin 4% solution (Adept, Shire Pharmaceuticals, UK) is a high-molecular-weight a-1,4 glucose polymer approved in Europe for use as intraoperative lavage and postoperative instillation to reduce the occurrence of post-surgery intra-abdominal adhesions. The present clinical study aimed to evaluate the safety and effectiveness of icodextrin 4% in decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASBO. Methods: The study was a single-center prospective, randomized investigation. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. Safety and efficacy of icodextrin 4% in the study group are compared to no anti-adhesion treatment in a parallel control group with blinded evaluation of primary endpoints. Primary endpoints are the evaluation of the therapeutic role of icodextrin 4% in reducing ASBO recurrence incidence and the need of laparotomies for ASBO recurrence, as well as adhesion formation (with evaluation of their incidence, extent, and severity). A sum of 181 patients with ASBO and surgical indication to laparotomy were enrolled and randomized in two groups. Patients were submitted to adhesiolysis with bowel resection if required with or without anastomosis. The first group received traditional treatment (control group), whereas the second group was treated with the addition of icodextrin 4% solution before the abdominal closure. Results: Ninety-one patients were randomized to have icodextrin 4% solution administered intraperitoneally, and 90 patients were randomized to have the traditional treatment. The two study groups were homogeneous regarding their baseline characteristics. The ASBO recurrence rate was 2.19% (2/91) in the icodextrin groups vs 11.11% (10/90) in the control group after a mean follow-up period of 41.4 months ( p < 0.05). No differences were found in the need of laparotomies for ASBO recurrence in the studied groups. The adhesion severity score seems lower in the group treated with the addition of icodextrin ( p = n.s.). Conclusions: The data resulting from this RCT showed that the use of icodextrin 4% solution in ASBO is safe and reduces intra-abdominal adhesion formation and the risk of re-obstruction. [ABSTRACT FROM AUTHOR]