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Properties of Spray-freeze-dried Products and their Characterization
Published in S. Padma Ishwarya, Spray-Freeze-Drying of Foods and Bioproducts, 2022
In yet another investigation by Niwa, Mizutani, & Danjo (2012), Ciclosporin – a poorly water-soluble model drug for respiratory delivery was loaded in mannitol (a carrier to improve dissolution) and then spray-freeze-dried. Different from the above studies, these researchers adopted two different methodologies to quantify the release rate of ciclosporin from the SFD composite particles: (1) soaking method in a large volume of medium and (2) filter permeation method in a small volume of medium. Probably, the above variations were studied since the systemic availability of dry powder inhalers (DPIs) is usually limited by the poor dissolution of their constituent API in limited physiological volumes of aqueous media (Labouta & Schneider, 2010). Also, the release pattern of API from the SFD particles were examined in a simulated respiratory fluid (phosphate-buffer solution containing 0.1% of Tween 80 at pH 6.6). The first method of dissolution testing involved a simple procedure in which a defined weight (in the order of milligrams) of the drug was placed into 100 mL of the dissolution medium at 37°C and then agitated at 300 rpm using magnetic stirrer. The latter was carried out in a specially designed system (Figure 10.13), which mimics the release process from particles that cling to the surface of bronchus and pulmonary mucosa (Niwa et al., 2012).
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Published in Sarfaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition, 2019
The dissolution testing apparatus used in this evaluation should conform to the requirements in USP (<711> Dissolution) and FDA’s guidance on Mechanical Calibration of Dissolution Apparatus 1 and 2.* Selection of the dissolution testing apparatus (USP Apparatus 1 or 2) during drug development should be based on a comparison of in vitro dissolution and in vivo PK data available for the product. The USP Apparatus 1 (basket method) is generally preferred for capsules and products that tend to float, and USP Apparatus 2 (paddle method) is generally preferred for tablets. For some tablet dosage forms, in vitro (but not in vivo) dissolution may be slow due to the manner in which the disintegrated product settles at the bottom of a dissolution vessel. In such situations, USP Apparatus 1 may be preferred over Apparatus 2, or alternatively rotation speed for Apparatus 2 may be modified with justification. If the testing conditions need to be modified to better reflect rapid in vivo dissolution (e.g., use of a different rotating speed), such modifications can be justified by comparing in vitro dissolution with in vivo absorption data (e.g., a relative BA study using a simple aqueous solution as the reference product).
Statistical Methods for Assessing Biosimilarity
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
In vivo bioequivalence studies are surrogate trials for assessing equivalence between test and reference formulations based on the rate and extent of drug absorption in humans to establish similar effectiveness and safety under the fundamental bioequivalence assumption. However, drug absorption depends on the dissolved state of drug product, and dissolution testing provides a rapid in vitro assessment of the rate and extent of drug release. Leeson (1995), therefore, suggested that in vitro dissolution testing be used as a surrogate for in vivo bioequivalence studies to assess equivalence between the test and reference formulations for postapproval changes. For the comparison of dissolution profiles, the FDA guidance suggests considering the assessment of (1) the overall profile similarity and (2) similarity at each sampling time point (FDA, 1997). Since dissolution profiles are curves over time, Chow and Ki (1997) introduced the concepts of local similarity and global similarity. Two dissolution profiles are said to be locally similar at a given time point if their difference or ratio at the given time point is within some equivalence (similarity) limits, denoted by (δL, δU). Two dissolution profiles are considered globally similar if their differences or ratios are within (δL, δU) across all time points. Note that global similarity is also known as uniformly similar. Chow and Ki (1997) suggested the following similarity limits for comparing dissolution profiles: δL=Q−δQ+δandδU=Q+δQ−δ
Process Analytical Technology, continuous manufacturing, and the development of a surrogate model for dissolution: a pharmaceutical manufacturing statistical engineering case study
Published in Quality Engineering, 2023
Stan Altan, Hans Coppenolle, Lynne Hare, Sarah Nielsen, Martin Otava
Typically, 6-24 tablets are measured in commercial production. A single time point criterion from the in vitro release profile, typically 30 minutes, is included in the set of chemical and physical properties associated with quality of the product. Dissolution testing can indicate the consistency of commercial batches with batches studied and used in human clinical trials. This linkage to batches used in clinical studies justifies a quality statement of acceptability for marketing purposes, since it would be impossible to study every manufactured batch in a clinical study.