Pulsatile Delivery

14,000,000 Leading Edge Experts on the ideXlab platform

Scan Science and Technology

Contact Leading Edge Experts & Companies

Scan Science and Technology

Contact Leading Edge Experts & Companies

The Experts below are selected from a list of 315 Experts worldwide ranked by ideXlab platform

Per Artursson - One of the best experts on this subject based on the ideXlab platform.

Erik Björk - One of the best experts on this subject based on the ideXlab platform.

A Gazzaniga - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of powder layering vs spray coating techniques in the manufacturing of a swellable erodible Pulsatile Delivery system
    Drug Development and Industrial Pharmacy, 2020
    Co-Authors: A Foppoli, Luca Palugan, Matteo Cerea, L Zema, A Maroni, A. Melocchi, A Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniqu...

  • Evaluation of powder-layering vs. spray-coating techniques in the manufacturing of a swellable/erodible Pulsatile Delivery system
    'Informa UK Limited', 2020
    Co-Authors: A Foppoli, Luca Palugan, L Zema, A Maroni, M. Cerea, A. Melocchi, A Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniques to achieve the functional hydroxypropyl methylcellulose (HPMC) layer. Although aqueous spray-coating has long been preferred, the processing times and yields still represent open issues, especially in view of the considerable amount of polymer required to give in vivo lag phases of proper duration. In order to make manufacturing of the Delivery system more cost-efficient, different coating modes were thus evaluated, namely top and tangential spray-coating as well as powder-layering, using a fluid bed equipment. To this aim, disintegrating tablets of 5 mm in diameter, containing a tracer drug, were coated up to 50% weight gain with low-viscosity HPMC, either as a water solution or as a powder formulation. In all cases, process feasibility was assessed following setup of the operating conditions. Irrespective of the technique employed, the resulting dosage forms exhibited uniform coating layers able to defer the onset of release as a function of the amount of polymer applied. The structure and thickness of such layers differed depending on the deposition modes. With respect to top spray-, both tangential spray-coating and powder-layering were shown to remarkably ameliorate the process time, which was reduced to approximately 1/3 and 1/6, and to enhance the yield by almost 20 and 30%, respectively. Clear advantages associated with such techniques were thus highlighted, particularly with respect to powder-layering here newly proposed for application of a swellable hydrophilic cellulose derivative

  • a novel injection molded capsular device for oral Pulsatile Delivery based on swellable erodible polymers
    Aaps Pharmscitech, 2011
    Co-Authors: A Gazzaniga, Matteo Cerea, A Maroni, Alberto Cozzi, A Foppoli, L Zema
    Abstract:

    The feasibility of injection molding was explored in the preparation of a novel capsular device for oral Pulsatile/delayed Delivery based on swellable/erodible polymers. For this purpose, a mold intended to be coupled with a bench-top injection-molding press was designed. This was expected to enable the preparation of matching capsule cap and body items within a single manufacturing cycle and the selection of differing shell thicknesses (300, 600, and 900 μm). Hydroxypropylcellulose (Klucel® EF, LF, and GF) was employed as the release-controlling polymer in admixture with polyethylene glycol 1500 (10%, w/w) as the plasticizer. After preliminary trials aimed at the setup of operating conditions, Klucel® EF and LF capsule shells with satisfactory technological properties were manufactured. The performance of capsular devices filled with a tracer drug powder was studied by means of a modified USP31 disintegration apparatus. Typical in vitro delayed release patterns were thereby obtained, with lag time increasing as a function of the wall thickness. A good correlation was found between the latter parameter and t 10%, i.e., the time to 10% release, for both polymer grades employed. On the basis of the overall results, the investigated technique was proven suitable for the manufacturing of an innovative Pulsatile release platform.

  • different hpmc viscosity grades as coating agents for an oral time and or site controlled Delivery system an investigation into the mechanisms governing drug release
    Journal of Pharmaceutical Sciences, 2007
    Co-Authors: L Zema, Luca Palugan, Anastasia Foppoli, Maria Edvige Sangalli, A Maroni, A Gazzaniga
    Abstract:

    Abstract When used as release‐controlling coating agents for tableted core‐based Pulsatile Delivery systems, three different hydroxypropyl methylcellulose (HPMC) grades, Methocel® E5, E50, and K4M, provided lag phases of varying duration (Methocel® K4M > E50 > E5) and a prompt and quantitative model drug release. Dissolution/mechanical erosion, permeability increase and disruption of the hydrated polymeric layer were assumed to participate in the definition of the overall release pattern. Based on these premises, we investigated what process(es) might prevail in the release‐controlling mechanism for each HPMC grade. The polymers were evaluated for dissolution and swelling, while the finished systems were concomitantly evaluated for drug release and polymer dissolution. The obtained results indicated likely similarities between Methocel® E5 and E50 performances, which we hypothesized to be mainly dissolution/erosion‐controlled, and a clearly different behavior for Methocel® K4M. This polymer indeed proved to yield higher viscosity and slower dissolving gel layer, which was able to withstand extensive dissolution/erosion for periods that exceeded the observed lag phases. The particular characteristics of swollen Methocel® K4M were shown to be associated with possible drug diffusion phenomena, which might impair the prompt and quantitative release phase that is typical of Pulsatile Delivery.

Andrea Gazzaniga - One of the best experts on this subject based on the ideXlab platform.

  • Evaluation of powder-layering vs. spray-coating techniques in the manufacturing of a swellable/erodible Pulsatile Delivery system.
    Drug development and industrial pharmacy, 2020
    Co-Authors: Anastasia Foppoli, Luca Palugan, Alessandra Maroni, Lucia Zema, Matteo Cerea, A. Melocchi, Andrea Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniqu...

  • Film coatings for oral Pulsatile release.
    International journal of pharmaceutics, 2013
    Co-Authors: Alessandra Maroni, Luca Palugan, Lucia Zema, G. Loreti, Andrea Gazzaniga
    Abstract:

    Pulsatile Delivery is generally intended as a release of the active ingredient that is delayed for a programmable period of time to meet particular chronotherapeutic needs and, in the case of oral administration, also target distal intestinal regions, such as the colon. Most oral Pulsatile Delivery platforms consist in coated formulations wherein the applied polymer serves as the release-controlling agent. When exposed to aqueous media, the coating initially performs as a protective barrier and, subsequently, undergoes a timely failure based on diverse mechanisms depending on its physico-chemical and formulation characteristics. Indeed, it may be ruptured because of the gradual expansion of the core, swell and/or erode due to the glassy-rubbery polymer transition or become permeable thus allowing the drug molecules to diffuse outwards. Otherwise, when the coating is a semipermeable membrane provided with one or more orifices, the drug is released through the latter as a result of an osmotic water influx. The vast majority of Pulsatile Delivery systems described so far have been prepared by spray-coating, which offers important versatility and feasibility advantages over other techniques such as press- and dip-coating. In the present article, the design, manufacturing and performance of spray-coated Pulsatile Delivery platforms is thus reviewed.

  • Polymeric coatings for a multiple-unit Pulsatile Delivery system: preliminary study on free and applied films.
    International journal of pharmaceutics, 2012
    Co-Authors: Alessandra Maroni, Anastasia Foppoli, Lucia Zema, Maria Dorly Del Curto, Matteo Cerea, Andrea Gazzaniga
    Abstract:

    In order to adapt a previously described swellable/erodible Pulsatile Delivery system to a multiple-unit configuration, insoluble films with adequate permeability and flexibility were proposed for application to its functional hydroxypropyl methylcellulose (HPMC) layer. By slowing down the penetration of water into the system, such films would be expected to improve the relevant effectiveness in delaying the onset of release without possibly impacting on the mechanism involved. Free films of Eudragit(®)NE containing differing amounts (10-20%) of a superdisintegrant, i.e. Explotab(®)V17, Ac-Di-Sol(®), Kollidon(®)CL or Kollidon(®)CL-M, were prepared by spraying technique and evaluated for hydration, permeability and tensile properties. The hydration and permeability characteristics were enhanced by the addition of the superdisintegrants, generally as a function of their concentration. Explotab(®)V17 was shown particularly useful to increase the film permeability. Moreover, it exerted a minor impact on the advantageous tensile properties of the acrylic polymer, especially in the wet state. Based on these results and on a preliminary release study performed with two-layer devices, the Eudragit(®)NE film with Explotab(®)V17 at the highest investigated percentage was identified as a potential formulation candidate for being applied to HPMC-coated cores thus allowing the onset of release to effectively be delayed by coatings of reduced thickness.

  • A Novel Injection-Molded Capsular Device for Oral Pulsatile Delivery Based on Swellable/Erodible Polymers
    AAPS PharmSciTech, 2011
    Co-Authors: Andrea Gazzaniga, Anastasia Foppoli, Alessandra Maroni, Matteo Cerea, Alberto Cozzi, Lucia Zema
    Abstract:

    The feasibility of injection molding was explored in the preparation of a novel capsular device for oral Pulsatile/delayed Delivery based on swellable/erodible polymers. For this purpose, a mold intended to be coupled with a bench-top injection-molding press was designed. This was expected to enable the preparation of matching capsule cap and body items within a single manufacturing cycle and the selection of differing shell thicknesses (300, 600, and 900 μm). Hydroxypropylcellulose (Klucel^® EF, LF, and GF) was employed as the release-controlling polymer in admixture with polyethylene glycol 1500 (10%, w / w ) as the plasticizer. After preliminary trials aimed at the setup of operating conditions, Klucel^® EF and LF capsule shells with satisfactory technological properties were manufactured. The performance of capsular devices filled with a tracer drug powder was studied by means of a modified USP31 disintegration apparatus. Typical in vitro delayed release patterns were thereby obtained, with lag time increasing as a function of the wall thickness. A good correlation was found between the latter parameter and t _10%, i.e., the time to 10% release, for both polymer grades employed. On the basis of the overall results, the investigated technique was proven suitable for the manufacturing of an innovative Pulsatile release platform.

  • Oral Pulsatile Delivery: rationale and chronopharmaceutical formulations.
    International journal of pharmaceutics, 2010
    Co-Authors: Alessandra Maroni, Lucia Zema, Maria Dorly Del Curto, Giulia Loreti, Andrea Gazzaniga
    Abstract:

    Oral Pulsatile/delayed Delivery systems are designed to elicit programmable lag phases preceding a prompt and quantitative, repeated or prolonged release of drugs. Accordingly, they draw increasing interest because of the inherent suitability for accomplishing chronotherapeutic goals, which have recently been highlighted in connection with a number of widespread chronic diseases with typical night or early-morning recurrence of symptoms (e.g. bronchial asthma, cardiovascular disease, rheumatoid arthritis, early-morning awakening). In addition, time-based colonic release can be attained when Pulsatile Delivery systems are properly adapted to overcome unpredictable gastric emptying and provide delay phases that would approximately match the small intestinal transit time. Oral Pulsatile Delivery is pursued by means of a variety of release platforms, namely reservoir, capsular and osmotic devices. The aim of the present review is to outline the rationale and main formulation strategies behind delayed-release dosage forms intended for the pharmacological treatment of chronopathologies.

Luca Palugan - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of powder layering vs spray coating techniques in the manufacturing of a swellable erodible Pulsatile Delivery system
    Drug Development and Industrial Pharmacy, 2020
    Co-Authors: A Foppoli, Luca Palugan, Matteo Cerea, L Zema, A Maroni, A. Melocchi, A Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniqu...

  • Evaluation of powder-layering vs. spray-coating techniques in the manufacturing of a swellable/erodible Pulsatile Delivery system.
    Drug development and industrial pharmacy, 2020
    Co-Authors: Anastasia Foppoli, Luca Palugan, Alessandra Maroni, Lucia Zema, Matteo Cerea, A. Melocchi, Andrea Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniqu...

  • Evaluation of powder-layering vs. spray-coating techniques in the manufacturing of a swellable/erodible Pulsatile Delivery system
    'Informa UK Limited', 2020
    Co-Authors: A Foppoli, Luca Palugan, L Zema, A Maroni, M. Cerea, A. Melocchi, A Gazzaniga
    Abstract:

    A swellable/erodible system for oral time-dependent release, demonstrated to provide consistent Pulsatile and colonic Delivery performance, has been manufactured through a range of coating techniques to achieve the functional hydroxypropyl methylcellulose (HPMC) layer. Although aqueous spray-coating has long been preferred, the processing times and yields still represent open issues, especially in view of the considerable amount of polymer required to give in vivo lag phases of proper duration. In order to make manufacturing of the Delivery system more cost-efficient, different coating modes were thus evaluated, namely top and tangential spray-coating as well as powder-layering, using a fluid bed equipment. To this aim, disintegrating tablets of 5 mm in diameter, containing a tracer drug, were coated up to 50% weight gain with low-viscosity HPMC, either as a water solution or as a powder formulation. In all cases, process feasibility was assessed following setup of the operating conditions. Irrespective of the technique employed, the resulting dosage forms exhibited uniform coating layers able to defer the onset of release as a function of the amount of polymer applied. The structure and thickness of such layers differed depending on the deposition modes. With respect to top spray-, both tangential spray-coating and powder-layering were shown to remarkably ameliorate the process time, which was reduced to approximately 1/3 and 1/6, and to enhance the yield by almost 20 and 30%, respectively. Clear advantages associated with such techniques were thus highlighted, particularly with respect to powder-layering here newly proposed for application of a swellable hydrophilic cellulose derivative

  • Film coatings for oral Pulsatile release.
    International journal of pharmaceutics, 2013
    Co-Authors: Alessandra Maroni, Luca Palugan, Lucia Zema, G. Loreti, Andrea Gazzaniga
    Abstract:

    Pulsatile Delivery is generally intended as a release of the active ingredient that is delayed for a programmable period of time to meet particular chronotherapeutic needs and, in the case of oral administration, also target distal intestinal regions, such as the colon. Most oral Pulsatile Delivery platforms consist in coated formulations wherein the applied polymer serves as the release-controlling agent. When exposed to aqueous media, the coating initially performs as a protective barrier and, subsequently, undergoes a timely failure based on diverse mechanisms depending on its physico-chemical and formulation characteristics. Indeed, it may be ruptured because of the gradual expansion of the core, swell and/or erode due to the glassy-rubbery polymer transition or become permeable thus allowing the drug molecules to diffuse outwards. Otherwise, when the coating is a semipermeable membrane provided with one or more orifices, the drug is released through the latter as a result of an osmotic water influx. The vast majority of Pulsatile Delivery systems described so far have been prepared by spray-coating, which offers important versatility and feasibility advantages over other techniques such as press- and dip-coating. In the present article, the design, manufacturing and performance of spray-coated Pulsatile Delivery platforms is thus reviewed.

  • Oral Pulsatile Delivery systems based on swellable hydrophilic polymers.
    European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 2007
    Co-Authors: Andrea Gazzaniga, Luca Palugan, Anastasia Foppoli, Maria Edvige Sangalli
    Abstract:

    Upon contact with aqueous fluids, swellable hydrophilic polymers undergo typical chain relaxation phenomena that coincide with a glassy-rubbery transition. In the rubbery phase, these polymers may be subject to swelling, dissolution and erosion processes or, alternatively, form an enduring gel barrier when cross-linked networks (hydrogels) are dealt with. Because of the peculiar hydration and biocompatibility properties, such materials are widely exploited in the pharmaceutical field, particularly as far as hydrophilic cellulose derivatives are concerned. In oral Delivery, they have for long been employed in the manufacturing of prolonged release matrices and, more recently, for Pulsatile (delayed) release devices as well. Pulsatile Delivery, which is meant as the liberation of drugs following programmed lag phases, has drawn increasing interest especially in view of emerging chronotherapeutic approaches. In pursuit of Pulsatile release, various design strategies have been proposed, chiefly including reservoir, capsular and osmotic formulations. In most cases, water-swellable polymers play a key role in the overall Delivery mechanism after being activated by physiological media. Based on these premises, the aim of the present review is to survey the main oral Pulsatile Delivery systems, for which swelling, dissolution and/or erosion of hydrophilic polymers are primarily involved in the control of release.

Related terms

Pulsatile Delivery - 15 days free trial to Access Experts & Abstracts