The Importance of Drug Delivery in the Clinical Development and Lifecycle of Drug Products with Examples from Authorised Medicinal Products DOI Open Access
Maria Malamatari

Processes, Год журнала: 2023, Номер 11(10), С. 2919 - 2919

Опубликована: Окт. 5, 2023

Drug delivery systems (DDS) are formulations or devices that enable the introduction of a therapeutic into body and its to target site, potentially enhancing efficacy safety. Advances in formulation approaches related enhancement solubility, permeability thus bioavailability drugs have already been successfully implemented by pharmaceutical industry. This review highlights importance formulations/DDS clinical development lifecycle drug products. Examples from authorised products used showcase how appropriate could deliver site action (e.g., pulmonary nasal delivery) enhance patient adherence medication long-acting injectables, 3D-printed tablets). Moreover, examples provided highlight can improve safety liposomes, abuse-deterrent opioid formulations) albumin-based nanoparticles, permeation enhancers for oral peptides).

Язык: Английский

Temperature mapping of milling by dual centrifugation: A systematic investigation DOI Creative Commons
Nadina Zulbeari,

Louise Ulrich Kristensen,

Stefan Mende

и другие.

International Journal of Pharmaceutics, Год журнала: 2024, Номер unknown, С. 124760 - 124760

Опубликована: Сен. 1, 2024

Язык: Английский

Процитировано

1

Machine learning strengthened formulation design of pharmaceutical suspensions DOI Creative Commons
Nadina Zulbeari, Fanjin Wang,

Sibel Selyatinova Mustafova

и другие.

International Journal of Pharmaceutics, Год журнала: 2024, Номер unknown, С. 124967 - 124967

Опубликована: Ноя. 1, 2024

Many different formulation strategies have been investigated to oppose suboptimal treatment of long-term or chronic conditions, one which are the nano- and microsuspensions prepared as long-acting injectables prolong release an active pharmaceutical compound for a defined period time by regulating size particles milling. Typically, surfactant and/or polymers added in dispersion medium suspension during processing stabilization purposes. However, current investigations with milling heavily based on prior expertise trial-and-error approaches. Various interacting parameters such bead size, stabilizer type concentration confounded investigation process. The present study systematically exploited statistical machine learning (ML) understand relationship between characteristics under full-factorial experiments. Stabilizer was identified significant factor (p < 0.001) median diameter (D

Язык: Английский

Процитировано

1

Two in One: Size Characterization and Accelerated Short-Term Physical Stability of Dual-Drug Suspensions with Two Acidic Compounds (Indomethacin and Naproxen) DOI Creative Commons
Nadina Zulbeari,

Sandrine Schiller Hansen,

René Holm

и другие.

Pharmaceutics, Год журнала: 2024, Номер 16(12), С. 1495 - 1495

Опубликована: Ноя. 21, 2024

Background/Objectives: Co-delivering dual-drug systems have proven to be effective in, for example, anticancer therapy or HIV prophylaxis due a higher target selectivity and therapeutic efficacy from compound synergism. However, various challenges regarding physical stability can arise during the formulation definition when multiple drug compounds are included in same formulation. In this work, focus was on aqueous suspensions, which could applied as long-acting injectable formulations release over weeks months after administration. Methods: It possible gain insights into nano- microsuspensions containing two acidic (indomethacin naproxen) prepared by milling with dual centrifugation. Information of individual suspensions subtracted compared conditions stored at elevated temperatures 40 °C. Results: Distinct particle size profiles were obtained dependent stabilizer used both suspensions. Most notably, combination indomethacin naproxen one resulted smaller sizes particles under presence some stabilizers. The further indicated that least model needed sufficiently stabilized obtain physically stable 28 days Similarly, distribution showed monomodal achieved demonstrated alone. Over 28-day period, smallest polysorbate 85 poloxamer 338 only single preparation, indicating tendencies towards stabilization synergism stabilizers well compounds. Conclusion: Overall, study preparation naproxen.

Язык: Английский

Процитировано

1

Small-Scale Aqueous Suspension Preparation using Dual Centrifugation: The Effect of Process Parameters on the Sizes of Drug Particles DOI Creative Commons
Nadina Zulbeari,

Nanna Einshøj Lund,

René Holm

и другие.

European Journal of Pharmaceutical Sciences, Год журнала: 2024, Номер 205, С. 106980 - 106980

Опубликована: Дек. 4, 2024

The dual centrifugation approach has in the recent years emerged as a powerful milling tool to prepare pharmaceutical suspensions submicron range with fast-milling capacity by 40 samples simultaneously 2 mL vials. While there is some standardized conditions described literature when preparing aqueous centrifugation, more systematic and experimental understanding of process evaluate impact different variables centrifuge on final sizes suspended drug particles independent compound used was desired. Overall, present study demonstrated applicability for small-scale screening purposes showed parameters physical attributes prepared suspensions. In work, rate size reduction three model compounds, i.e., cinnarizine, haloperidol, indomethacin, found be mostly influenced speed, beads, bead loading during milling, whereas rotor temperature did not affect particle profiles stabilized polysorbate 20 centrifugation. Smaller were general obtained at highest intensity, 1500 rpm, smallest size, 0.2 mm, higher loadings (42 %, 56 83 %). grinding limit approximately 0.50 µm, 0.70 0.35 µm respectively, achieved relatively fast, 30 min specified conditions, compared milled larger (i.e., 1.0 mm), lower intensities (e.g., 1000 rpm), 14 or 28 further confirmed that intensity necessary haloperidol probably due compounds predominantly plastic properties. Sizes indomethacin increased longer runs up 240 also % %. These observations supported color conversion from white yellow which indicated generation small quantities amorphic material after high intensity. Upscale investigations comparable all while rpm five minutes.

Язык: Английский

Процитировано

1

The Importance of Drug Delivery in the Clinical Development and Lifecycle of Drug Products with Examples from Authorised Medicinal Products DOI Open Access
Maria Malamatari

Processes, Год журнала: 2023, Номер 11(10), С. 2919 - 2919

Опубликована: Окт. 5, 2023

Drug delivery systems (DDS) are formulations or devices that enable the introduction of a therapeutic into body and its to target site, potentially enhancing efficacy safety. Advances in formulation approaches related enhancement solubility, permeability thus bioavailability drugs have already been successfully implemented by pharmaceutical industry. This review highlights importance formulations/DDS clinical development lifecycle drug products. Examples from authorised products used showcase how appropriate could deliver site action (e.g., pulmonary nasal delivery) enhance patient adherence medication long-acting injectables, 3D-printed tablets). Moreover, examples provided highlight can improve safety liposomes, abuse-deterrent opioid formulations) albumin-based nanoparticles, permeation enhancers for oral peptides).

Язык: Английский

Процитировано

3