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Journal of Pharmaceutical Sciences Jul 2024The production of paediatric pharmaceutical forms represents a unique challenge within the pharmaceutical industry. The primary goal of these formulations is to ensure... (Review)
Review
The production of paediatric pharmaceutical forms represents a unique challenge within the pharmaceutical industry. The primary goal of these formulations is to ensure therapeutic efficacy, safety, and tolerability in paediatric patients, who have specific physiological needs and characteristics. In recent years, there has been a significant increase in attention towards this area, driven by the need to improve drug administration to children and ensure optimal and specific treatments. Technological innovation has played a crucial role in meeting these requirements, opening new frontiers in the design and production of paediatric pharmaceutical forms. In particular, three emerging technologies have garnered considerable interest and attention within the scientific and industrial community: 3D printing, prilling/vibration, and microfluidics. These technologies offer advanced approaches for the design, production, and customization of paediatric pharmaceutical forms, allowing for more precise dosage modulation, improved solubility, and greater drug acceptability. In this review, we delve into these cutting-edge technologies and their impact on the production of paediatric pharmaceutical forms. We analyse their potential, associated challenges, and recent developments, providing a comprehensive overview of the opportunities that these innovative methodologies offer to the pharmaceutical sector. We examine different pharmaceutical forms generated using these techniques, evaluating their advantages and disadvantages.
Topics: Printing, Three-Dimensional; Humans; Child; Microfluidics; Dosage Forms; Technology, Pharmaceutical; Pediatrics; Pharmaceutical Preparations; Drug Compounding; Chemistry, Pharmaceutical; Solubility
PubMed: 38582283
DOI: 10.1016/j.xphs.2024.04.001 -
International Journal of Molecular... Sep 2010Controlled release delivery is available for many routes of administration and offers many advantages (as microparticles and nanoparticles) over immediate release... (Review)
Review
Controlled release delivery is available for many routes of administration and offers many advantages (as microparticles and nanoparticles) over immediate release delivery. These advantages include reduced dosing frequency, better therapeutic control, fewer side effects, and, consequently, these dosage forms are well accepted by patients. Advances in polymer material science, particle engineering design, manufacture, and nanotechnology have led the way to the introduction of several marketed controlled release products and several more are in pre-clinical and clinical development.
Topics: Biocompatible Materials; Biodegradable Plastics; Delayed-Action Preparations; Drug Carriers
PubMed: 20957095
DOI: 10.3390/ijms11093298 -
Pharmaceutical Research May 2017Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are... (Review)
Review
Pharmaceutical solid dosage forms (tablets or capsules) are the predominant form to administer active pharmaceutical ingredients (APIs) to the patient. Tablets are typically powder compacts consisting of several different excipients in addition to the API. Excipients are added to a formulation in order to achieve the desired fill weight of a dosage form, to improve the processability or to affect the drug release behaviour in the body. These complex porous systems undergo different mechanisms when they come in contact with physiological fluids. The performance of a drug is primarily influenced by the disintegration and dissolution behaviour of the powder compact. The disintegration process is specifically critical for immediate-release dosage forms. Its mechanisms and the factors impacting disintegration are discussed and methods used to study the disintegration in-situ are presented. This review further summarises mathematical models used to simulate disintegration phenomena and to predict drug release kinetics.
Topics: Capsules; Chemistry, Pharmaceutical; Excipients; Humans; Powders; Solubility; Tablets; Technology, Pharmaceutical
PubMed: 28251425
DOI: 10.1007/s11095-017-2129-z -
European Journal of Pharmaceutical... Aug 2023Fused deposition modeling (FDM) and selective laser sintering (SLS) are two of the most employed additive manufacturing (AM) techniques within the pharmaceutical...
Fused deposition modeling (FDM) and selective laser sintering (SLS) are two of the most employed additive manufacturing (AM) techniques within the pharmaceutical research field. Despite the numerous advantages of different AM methods, their respective drawbacks have yet to be fully addressed, and therefore combinatorial systems are starting to emerge. In the present study, hybrid systems comprising SLS inserts and a two-compartment FDM shell are developed to achieve controlled release of the model drug theophylline. Via the use of SLS a partial amorphization of the drug is demonstrated, which can be advantageous in the case of poorly soluble drugs, and it is shown that sintering parameters can regulate the dosage and release kinetics of the drug from the inserts. Furthermore, via different combinations of inserts within the FDM-printed shell, various drug release patterns, such as a two-step or prolonged release, can be achieved. The study serves as a proof of concept, highlighting the advantages of combining two AM techniques, both to overcome their respective shortcomings and to develop modular and highly tunable drug delivery devices.
Topics: Pharmaceutical Preparations; Drug Liberation; Drug Delivery Systems; Theophylline; Printing, Three-Dimensional; Technology, Pharmaceutical; Dosage Forms; Tablets
PubMed: 37277047
DOI: 10.1016/j.ejps.2023.106486 -
Expert Opinion on Drug Delivery 2016Nanosuspensions combine the advantages of nanotherapeutics (e.g. increased dissolution rate and saturation solubility) with ease of commercialisation. Transformation of... (Review)
Review
INTRODUCTION
Nanosuspensions combine the advantages of nanotherapeutics (e.g. increased dissolution rate and saturation solubility) with ease of commercialisation. Transformation of nanosuspensions to solid oral and inhalable dosage forms minimises the physical instability associated with their liquid state, enhances patient compliance and enables targeted oral and pulmonary drug delivery.
AREAS COVERED
This review outlines solidification methods for nanosuspensions. It includes spray and freeze drying as the most widely used techniques. Fluidised-bed coating, granulation and pelletisation are also discussed as they yield nanocrystalline formulations with more straightforward downstream processing to tablets or capsules. Spray-freeze drying, aerosol flow reactor and printing of nanosuspensions are also presented as promising alternative solidification techniques. Results regarding the solid state, in vitro dissolution and/or aerosolisation efficiency of the nanocrystalline formulations are given and combined with available in vivo data. Focus is placed on the redispersibility of the solid nanocrystalline formulations, which is a prerequisite for their clinical application.
EXPERT OPINION
A few solidified nanocrystalline products are already on the market and many more are in development. Oral and inhalable nanoparticle formulations are expected to have great potential especially in the areas of personalised medicine and delivery of high drug doses (e.g. antibiotics) to the lungs, respectively.
Topics: Administration, Inhalation; Chemistry, Pharmaceutical; Dry Powder Inhalers; Excipients; Freeze Drying; Nanoparticles; Solubility; Tablets
PubMed: 26764574
DOI: 10.1517/17425247.2016.1142524 -
International Journal of Molecular... Jun 2021In order to overcome the limitations associated with vaginal administration of drugs, e.g., the short contact time of the drug form with the mucosa or continuous carrier... (Review)
Review
In order to overcome the limitations associated with vaginal administration of drugs, e.g., the short contact time of the drug form with the mucosa or continuous carrier wash-out, the development of new carriers for gynecological use is necessary. Furthermore, high individual anatomical and physiological variability resulting in unsatisfactory therapeutic efficacy of lipophilic active substances requires application of multicompartment drug delivery systems. This manuscript provides an up-to-date comprehensive review of the literature on emulsion-based vaginal dosage forms (EVDF) including macroemulsions, microemulsions, nanoemulsions, multiple emulsions and self-emulsifying drug delivery systems. The first part of the paper discusses (i) the influence of anatomical-physiological conditions on therapeutic efficacy of drug forms after local and systemic administration, (ii) characterization of EVDF components and the manufacturing techniques of these dosage forms and (iii) methods used to evaluate the physicochemical and pharmaceutical properties of emulsion-based vaginal dosage forms. The second part of the paper presents (iv) the results of biological and in vivo studies as well as (v) clinical evaluation of EVDF safety and therapeutic efficacy across different indications.
Topics: Administration, Intravaginal; Chemical Phenomena; Drug Carriers; Drug Compounding; Drug Delivery Systems; Emulsions; Female; Humans; Microbiota; Mucous Membrane; Pharmaceutical Preparations; Theranostic Nanomedicine
PubMed: 34208652
DOI: 10.3390/ijms22126455 -
European Journal of Pharmaceutical... Mar 2023Therapeutic proteins and peptides (TPPs) are increasingly favoured above small drug molecules due to their high specificity to the site of action and reduced adverse... (Review)
Review
Therapeutic proteins and peptides (TPPs) are increasingly favoured above small drug molecules due to their high specificity to the site of action and reduced adverse effects resulting in increased use of these agents for medical treatments and therapies. Consequently, there is a need to formulate TPPs in dosage forms that are accessible and suitable for a wide range of patient groups as the use of TPPs becomes increasingly prevalent in healthcare settings worldwide. Orally disintegrating dosage forms (ODDF) are formulations that can ensure easy-to-administer medication to a wider patient population including paediatrics, geriatrics and people in low-resource countries. There are many challenges involved in developing suitable pharmaceutical strategies to protect TPPs during formulation and manufacturing, as well as storage, and maintenance of a cold-chain during transportation. This review will discuss advances being made in the research and development of pharmaceutical and manufacturing strategies used to incorporate various TPPs into ODDF systems.
Topics: Child; Humans; Administration, Oral; Dosage Forms; Drug Delivery Systems; Peptides; Pharmaceutical Preparations; Tablets; Aged
PubMed: 36623699
DOI: 10.1016/j.ejps.2023.106374 -
Journal of Controlled Release :... Sep 2014Because of their large surface area and immunological competence, mucosal tissues are attractive administration and target sites for vaccination. An important... (Review)
Review
Because of their large surface area and immunological competence, mucosal tissues are attractive administration and target sites for vaccination. An important characteristic of mucosal vaccination is its ability to elicit local immune responses, which act against infection at the site of pathogen entry. However, mucosal surfaces are endowed with potent and sophisticated tolerance mechanisms to prevent the immune system from overreacting to the many environmental antigens. Hence, mucosal vaccination may suppress the immune system instead of induce a protective immune response. Therefore, mucosal adjuvants and/or special antigen delivery systems as well as appropriate dosage forms are required in order to develop potent mucosal vaccines. Whereas oral, nasal and pulmonary vaccine delivery strategies have been described extensively, the sublingual and buccal routes have received considerably less attention. In this review, the characteristics of and approaches for sublingual and buccal vaccine delivery are described and compared with other mucosal vaccine delivery sites. We discuss recent progress and highlight promising developments in the search for vaccine formulations, including adjuvants and suitable dosage forms, which are likely critical for designing a successful sublingual or buccal vaccine. Finally, we outline the challenges, hurdles to overcome and formulation issues relevant for sublingual or buccal vaccine delivery.
Topics: Administration, Buccal; Administration, Sublingual; Delayed-Action Preparations; Dosage Forms; Drug Delivery Systems; Humans; Vaccines
PubMed: 24911355
DOI: 10.1016/j.jconrel.2014.05.060 -
International Journal of Pharmaceutics Mar 2019In pharmaceutical technology, lipids and polymers are considered pillar excipients for the fabrication of most dosage forms, irrespective of the administration route.... (Review)
Review
In pharmaceutical technology, lipids and polymers are considered pillar excipients for the fabrication of most dosage forms, irrespective of the administration route. They play various roles ranging from support vehicles to release rate modifiers, stabilizers, solubilizers, permeation enhancers and transfection agents. Focusing on selected applications, which were discussed at the Annual Scientific Meeting of the Gattefossé Foundation 2018, this manuscript recapitulates the fundamental roles of these two important classes of excipients, either employed alone or in combination, and provides insight on their functional properties in various types of drug formulations. Emphasis is placed on oral formulations for the administration of active pharmaceutical ingredients with low aqueous solubilities or poor permeation properties. Additionally, this review article covers the use of lipids and polymers in the design of colloidal injectable delivery systems, and as substrates in additive manufacturing technologies for the production of tailor-made dosage forms.
Topics: Administration, Oral; Animals; Dosage Forms; Drug Carriers; Excipients; Humans; Lipids; Nanoparticles; Polymers; Printing, Three-Dimensional; Technology, Pharmaceutical
PubMed: 30639218
DOI: 10.1016/j.ijpharm.2018.12.080 -
European Journal of Pharmaceutics and... Oct 2021Foams are multiphase systems found throughout nature. We meet them equally often in our everyday life, starting with the foam in the morning espresso, where the foam... (Review)
Review
Foams are multiphase systems found throughout nature. We meet them equally often in our everyday life, starting with the foam in the morning espresso, where the foam should constitute 10% of the drink or in a glass of beer and ending with the evening bath with foam. These multiphase systems consist mainly of gas, which is separated by liquid or solid lamellae. The lamellae have a very large surface area and a small thickness, which results in their low stability. The foams in pharmaceutics are known for a long time as protective or therapeutic preparations for topical use. However, the physicochemical structure of both solid and liquid foams offers multiple fields of application in the modern therapy. For instance, owing to the unique structure, foams can be also used for parenteral use in the form of implants serving as a drug carrier and at the same time, a scaffold for regenerating the tissue. Foams can also be used orally in the form of controlled drug delivery systems that are potentially useful for sustained or targeted drug delivery. The article describes the unique advantages and features of foams that make them useful in modern pharmacotherapy.
Topics: Administration, Topical; Animals; Chemistry, Pharmaceutical; Delayed-Action Preparations; Dosage Forms; Drug Carriers; Drug Delivery Systems; Humans; Pharmaceutical Preparations
PubMed: 34325002
DOI: 10.1016/j.ejpb.2021.07.012