Inhalation Products Research Articles

The Effectiveness of Herbal Inhaler Products, Suan Sunandha Palace Recipe

This research purpose for Study the effectiveness of the herbal inhalant product, Wang Suan Sunandha recipe. This is quasi-experimental research with a single group pretest-posttest design. The experimental group is Suan Sunandha Rajabhat University students aged 18-25 years. Be healthy and have no chronic diseases. Consented to be research volunteers, totaling 50 people (25 males, 25 females). The research instrument is 1 questionnaire, divided into 4 parts, consisting of questionnaires and personal information of the sample group. Vital signs recording form Emotion and Feeling Assessment and Satisfaction Questionnaire An experiment was conducted where a sample of 50 people had their vital signs measured. and record the emotions before and after inhaling the herbal inhaler aroma Suan Sunandha Palace recipe, about 10 minutes. and after the end of the sample group, they self-assessed their satisfaction. The data was analyzed using descriptive statistics, finding frequency, percentage, mean, and standard deviation. and the use of paired t-test statistics. The results of the research found that after inhaling the scent of herbal inhalers, Suan Sunandha Palace Recipe It was found that vital signs (blood pressure and heart rate). The emotions and feelings of the sample group were different from before inhaling the herbal inhalant scent. Suan Sunandha Palace Recipe Statistically significant at the.05 level. But the breathing rate before and after inhaling the herbal inhaler odor Suan Sunandha Palace Recipe was no different, and the average satisfaction score of the sample was at the highest level.

Derived cannabinoid product availability among online vape shops

ObjectivesTo determine the proportion of online vape shops that offer derived cannabinoid products in a large metropolitan area (San Diego, California), measure their compliance with state hemp regulations, and estimate whether these shops receive more website traffic compared to those that offered nicotine or tobacco. MethodsWe obtained vape shops (n = 109) using browser-based (i.e., Google Search) and map-based (i.e., Google Maps and Yelp) searches in San Diego from March to August 2023 and conducted a content analysis of their websites to identify derived cannabinoid products offered for mail-order purchasing. Using website traffic data, we examined the association between derived cannabinoid product availability and monthly website visits. ResultsAmong the 109 online vape shops in the study sample, 35.8 % offered derived cannabinoid products for mail-order purchase and 26.6 % sold flavored (excluding terpenes) and inhalable cannabinoid products. Compared to vape shops that did not offer derived cannabinoid products (Mean: 23,619; 95 % CI: 23,605–23,634), those offering flavored and inhalable cannabinoid products received 2.5 times more monthly website visits (Mean: 57,950; 95 % CI: 57,913–57,986) and those offering any derived cannabinoid products received 5.5 times more monthly website visits (Mean: 130,694; 95 % CI: 130,607–130,782). ConclusionThe prevalence of flavored and inhalable derived cannabinoid products, despite being prohibited under California’s hemp regulations, highlights the need for additional enforcement measures to ensure retailer compliance. The higher website traffic observed among vape shops offering cannabinoid products may be indicative of greater popularity of retailers selling derived cannabinoid products compared to those selling nicotine or tobacco products alone.

Pulmonary delivery of forsythin-phospholipid complexes improves the lung anti-inflammatory efficacy in mice by enhancing dissolution and lung tissue affinity

Forsythin, currently in phase II clinical trials in China for the treatment of the common cold and influenza, faces challenges in achieving adequate lung drug exposure due to its limited dissolution and permeability, thereby restricting its therapeutic efficacy. The objective of this work was to formulate a forsythin-phospholipid complex (FPC) to enhance its dissolution properties and lung affinity with a particular view to improving pulmonary drug exposure and anti-inflammatory response. The results revealed that forsythin reacted with dipalmitoyl-phosphatidylcholine to form a stable, nanosized FPC suspension. This formulation significantly improved the in vitro drug's dissolution, cellular uptake, and lung affinity compared to its uncomplexed form. Intratracheal administration of FPC in a mouse model of acute lung injury induced by lipopolysaccharide (LPS) resulted in a substantial increase in drug exposure to lung tissues (39.6-fold) and immune cells in the epithelial lining fluid (198-fold) compared to intraperitoneal injection. In addition, FPC instillation exhibited superior local anti-inflammatory effects, leading to improved survival rates among mice with LPS-induced acute respiratory distress syndrome, outperforming both instilled forsythin and injected FPC. Overall, this work demonstrated the potential of phospholipid complexes as a viable option for developing inhalation products for drugs with limited solubility and permeability properties.

Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.

Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products approved in Europe and some other geographic areas. The approved labels of the orally inhaled drug products recommend the maximum number of actuations that can be administered in a single dose on one occasion. This single maximum dose may consist of one or more inhalations depending upon the product. Bioequivalence studies for the inhalation drug product registrations in the US and EU have employed single and multiple actuation doses, in some cases over and above the approved single maximum labeled doses, thus, inconsistent with the approved labeling of the reference products. Pharmacokinetics of inhaled drug products after single and multiple doses may be different, with implications for bioequivalence determined at single and multiple doses. Scientific literature indicates that the relative bioavailability of the Test and Reference products may differ between administrations of doses in one and multiple inhalations. Multiple doses not only alter the pharmacokinetics but also may reduce the sensitivity of the bioassay to actual differences between the Test and Reference product performances. Ability of the pharmacokinetic bioassay to accurately determine the extent of difference between two products may also be substantially reduced at high doses. Therefore, in our opinion, pharmacokinetic bioequivalence to support regulatory approvals of inhalation products at doses above the recommended single maximum dose should be avoided. Furthermore, the bioequivalence of products (if any) established at doses exceeding the approved single maximum doses should be revisited to determine if the products maintain bioequivalence when evaluated at the clinically relevant single maximum doses.

Clinically Relevant Characterization and Comparison of Ryaltris and Other Anti-Allergic Nasal Sprays.

The deposition, residence time, and dissolution profile of nasal suspensions containing corticosteroids play a key role in their in vivo efficacy after administration. However, the conventional methods available to characterize nasal products appear to be unsuitable to exhaustively cover these aspects. The work aims to investigate technological aspects of Ryaltris (mometasone furoate and olopatadine hydrochloride nasal spray) compared to other commercial anti-allergic nasal products, namely, Dymista (azelastine hydrochloride and fluticasone propionate), Nasonex (mometasone furoate), and Avamys (fluticasone furoate). Innovative characterization methods were combined with more traditional approaches to investigate the anti-allergic nasal sprays. These methods applied together allowed to differentiate between the different products and provided a clear picture of the nasal product behavior in terms of drug dissolution and deposition. In particular, the dissolution tests were performed exploiting the Respicell® apparatus, an innovative technique that allows for the investigation of inhalation products. Then, formulation viscosities were considered along with a formulation flow test on an inclined plane. Finally, the intranasal deposition profile of the commercial formulations was determined using a silicon nasal cast. The results highlight in vitro significant differences in terms of viscosity as well as dissolution rate of the nasal products, with Ryaltris showing a higher viscosity and lower flow compared to other products, which, along with a corticosteroid faster dissolution rate than Dymista, suggest a potential advantage in terms of clinical behavior.

Branding in a Budding Industry: The Influence of Visual Cues on Consumer Behavior in the Cannabis Market

This study investigates the impact of visual branding cues on consumer responses in the cannabis market. Visual communication plays a critical role in shaping consumer behavior and perception. However, limited research exists on how consumers evaluate visual branding cues in the context of cannabis products. This study focuses on the effects of branded versus unbranded cannabis packaging for edible and inhalable products. It explores consumer product trust, product attitude, purchase intention, and willingness to pay in relation to visual branding cues. By investigating the impact of visual branding cues in the cannabis market, this study contributes new insights into the applicability of cue utilization theory and the theory of reasoned actions through this novel context.

Medical Cannabis for Patients Over Age 50: A Multi-site, Prospective Study of Patterns of Use and Health Outcomes

Objective: Cannabis is being used as a therapeutic option by patients around the globe, and older patients represent a rapidly growing subset of this population. This study aims to assess the patterns of medical cannabis use in patients over 50 years of age and its effect on health outcomes such as pain, sleep, quality of life, and co-medication. Method: The Medical Cannabis in Older Patients Study (MCOPS) is a multi-site, prospective observational study examining the real-world impact of medical cannabis use on patients over age 50 under the guidance of a health care provider. The study included validated instruments, with treating physicians collecting detailed data on participant characteristics, medical cannabis and co-medication use, and associated impacts on pain, sleep, quality of life, as well as adverse events. Results: Inclusion criteria were met by 299 participants. Average age of participants was 66.7 years, and 66.2% of respondents identified as female. Approximately 90% of patients used medical cannabis to treat pain-related conditions such as chronic pain and arthritis. Almost all patients reported a preference for oral cannabis products (e.g., extracts, edibles) rather than inhalation products (e.g., flower, vapes), and most preferred oral formulations high in cannabidiol and low in tetrahydrocannabinol. Over the six-month study period, significant improvements were noted in pain, sleep, and quality of life measures, with 45% experiencing a clinically meaningful improvement in pain interference and in sleep quality scores. Additionally, nearly 50% of patients taking co-medications at baseline had reduced their use by the end of the study period, and quality of life improved significantly from baseline to M3 and from baseline to M6, with an incremental cost per quality-adjusted life-year (QALY) of $25,357.20. No serious adverse events (SAEs) were reported. Conclusions: In this cohort of older patients, most of whom suffered from pain-related conditions, medical cannabis seemed to be a safe and effective treatment. Most patients experienced clinically significant improvements in pain, sleep, and quality of life and reductions in co-medication. The cost per QALY was well below the standard for traditional pharmaceuticals, and no SAEs were reported, suggesting that cannabis is a relatively safe and cost-effective therapeutic option for adults dealing with age-related health conditions.

Quantitative Estimation of 10 Known Impurities from Indacaterol Acetate, Glycopyrronium, and Mometasone Furoate Dry Powder Inhalation Product

Quantitative Estimation of 10 Known Impurities from Indacaterol Acetate, Glycopyrronium, and Mometasone Furoate Dry Powder Inhalation Product

Nanoscale colocalized thermal and chemical mapping of pharmaceutical powder aerosols

Inhalation of pharmaceutical aerosol formulations is widely used to treat respiratory diseases. Spatially resolved thermal characterization offers promise for better understanding drug release rates from particles; however, this has been an analytical challenge due to the small particle size (from a few micrometers down to nanometers) and the complex composition of the formulations. Here, we employ nano-thermal analysis (nanoTA) to probe the nanothermal domain of a pharmaceutical aerosol formulation containing a mixture of fluticasone propionate (FP), salmeterol xinafoate (SX), and excipient lactose, which is widely used to treat asthma and chronic obstructive pulmonary disease (COPD). Furthermore, atomic force microscopy-infrared spectroscopy (AFM-IR) and AFM force measurements are performed to provide nanochemical and nanomechanical information to complement the nanothermal data. The colocalized thermal and chemical mapping clearly reveals the surface heterogeneity of the drugs in the aerosol particles and demonstrates the contribution of the surface chemical composition to the variation in the thermal properties of the particles. We present a powerful analytical approach for in-depth characterization of thermal/chemical/morphological properties of dry powder inhaler particles at micro- and nanometer scales. This approach can be used to facilitate the comparison between generics and reference inhalation products and further the development of high-performance pharmaceutical formulations.

Simulated pharmacokinetics of inhaled caffeine and melatonin from existing products indicate the lack of dosimetric considerations

Numerous commercially available inhalable products claim to improve sleep-wake cycle-related target indications by delivering a wide variety of chemicals like caffeine and melatonin. The resulting exposure-responses from inhaling different doses are unknown and obtaining early understanding of resulting pharmacokinetics is beneficial. This study applied a physiologically based pharmacokinetic modeling approach to predict the inhalation pharmacokinetics of caffeine and melatonin for different target indications related to the sleep-wake cycle. The model predicted rapid systemic delivery of caffeine and melatonin based on airway regional deposition of inhaled aerosol. A low inhaled dose of 1 mg of caffeine resulted in a 72.3-times lower plasma maximal concentration and was predicted to not improve cognitive performance task outcomes compared to oral consumption of coffee containing 80 mg of caffeine. Conversely, 2-mg oral and inhaled doses of melatonin under recommended directions of use result in more than 25.1- and 645-times higher plasma concentrations compared to endogenous melatonin, respectively. The recommended doses for inhalation products for potential improvement in the target indications vary widely. Additional research is needed to evaluate the human pharmacokinetics, efficacy, and safety of inhaled products. Given the lack of assessments, inhaled caffeine and melatonin must be consumed with caution as the toxicological concerns are not known and could outweigh the potential beneficial effects.

Drug solubility in biorelevant media in the context of an inhalation-based biopharmaceutics classification system (iBCS)

An inhalation-based Biopharmaceutics Classification System for pulmonary drugs (iBCS) holds the perspective to allow for scientifically sound prediction of differences in the in vivo performance of orally inhaled drug products (OIDPs).A set of nine drug substances were selected, that are administered via both the oral and pulmonary routes. Their solubility was determined in media representative for the oral (Fasted State Simulated Intestinal Fluid (FaSSIF)) and pulmonary (Alveofact medium and Simulated Lung Fluid (SLF)) routes of administration to confirm the need for a novel approach for inhaled drugs. The complexity of these media was then stepwise reduced with the purpose of understanding the contribution of their components to the solubilizing capacity of the media. A second reason for varying the complexity was to identify a medium that would allow robust but accurate dissolution testing. Hence, Hank’s balanced salt solution (HBSS) as a medium used in many in vitro biological tests, non-buffered saline solution, and water were included.For some drug substances (salbutamol sulfate, tobramycin, isoniazid, and tiotropium bromide), no significant differences were observed between the solubility in the media used. For other drugs, however, we observed either just small (rifampicin, budesonide, salmeterol) or unexpectedly large differences (beclomethasone dipropionate).Based on the minimum theoretical solubility required for their common pulmonary dose in 10 ml of lung lining fluid, drug solubility was classified as either high or low. Two high solubility and two low solubility compounds were then selected for refined solubility testing in pulmonary relevant media by varying their content of phospholipids, surfactant proteins and other proteins.The solubility of drug substances in simulated lung lining fluids was found to be dependent on the physicochemical properties of the drug substance and the composition of the media. While a pulmonary dissolution medium that would fit all drugs could not be established, our approach may provide guidance for finding the most suitable dissolution medium for a given drug substance and better designing in vitro tests for predicting the in vivo performance of inhalable drug products.

Effects of flavour and modified risk claims on nicotine pouch perceptions and use intentions among young adults who use inhalable nicotine and tobacco products: a randomised controlled trial.

Availability of flavours and potential modified risk tobacco product (MRTP) claims may influence young adults' (YAs') perceptions of and intentions to use nicotine pouches ('pouches'). YAs aged 21-34 years (N=47, M age=24.5, SD=3.1) with past-month nicotine/tobacco use (10.6% cigarette-only, 51.1% e-cigarette-only, 38.3% dual use) and no intention to quit were randomised to self-administer four Zyn 3 mg nicotine pouches in a 4 (flavour; within-subjects: smooth, mint, menthol, citrus) × 2 (MRTP claim on packaging; between subjects: present or absent) mixed-factorial design. After self-administering each pouch, participants reported appeal, use intentions and perceived harm compared with cigarettes and e-cigarettes. Three mixed-factorial analysis of variances (ANOVAs) examined main and interactive effects of flavour and MRTP claim on appeal, use intentions and comparative harm perceptions. Mint (M=55.9, SD=26.4), menthol (M=49.7, SD=26.8) and citrus (M=46.6, SD=24.8) flavours were significantly more appealing than smooth (M=37.6, SD=25.4; p<0.001). MRTP claim did not significantly affect product appeal (p=0.376). Use intentions were greater for mint (M=2.6, SD=1.3) and menthol (M=2.0, SD=1.1) flavours than smooth (M=1.8, SD=1.0; p=0.002). Flavour did not affect comparative harm perceptions (p values>0.418). MRTP claims increased use intention (p=0.032) and perceptions of pouches as less harmful than cigarettes (p=0.011), but did not affect perceived harm relative to e-cigarettes (p=0.142). Flavour × MRTP claim interactions were not significant. Flavoured (vs smooth) pouches were more appealing to YAs. MRTP claims reduced perceived harm of pouches compared with cigarettes; however, intentions to switch were low. To protect YAs' health, regulatory restrictions could target flavours and MRTP claims.

An Approach to Flavor Chemical Thermal Degradation Analysis.

Toxicological evaluations of flavor chemicals for use in inhalation products that utilize heat for aerosol generation are complicated because of the potential effect heat may have on the flavor chemical. The objective was to develop a thermal degradation technique to screen flavor chemicals as part of a toxicological testing program for their potential use in ENDS formulations. Based upon published data for acetaldehyde, acrolein, and glycidol from ENDS products (common thermal degradants of propylene glycol and glycerin), the pyrolizer temperature was adjusted until a similar ratio of acetaldehyde, acrolein, and glycidol was obtained from a 60/40 ratio (v/v) of glycerin/propylene glycol via GC/MS analysis. For each of 90 flavor chemicals, quantitative measurements of acetaldehyde, acrolein, and glycidol, in addition to semiquantitative non-targeted analysis tentatively identifying chemicals from thermal degradation, were obtained. Twenty flavor chemicals transferred at greater than 99% intact, another 26 transferred at greater than 95% intact, and another 15 flavor chemicals transferred at greater than 90% intact. Most flavor chemicals resulted in fewer than 10-12 tentatively identified thermal degradants. The practical approach to the thermal degradation of flavor chemicals provided useful information as part of the toxicological evaluation of flavor chemicals for potential use in ENDS formulations.

Simultaneous UPLC Assay for Oxitropium Bromide and Formoterol Fumarate Dihydrate in Pressurized Metered Dose Inhaler Products for Chronic Obstructive Pulmonary Disease.

Oxitropium bromide (OB) and formoterol fumarate dihydrate (FFD) are inhaler molecules that are widely used in the treatment of chronic lung diseases. The goal of this work was to create a reversed phase-ultra performance liquid chromatography (RP-UPLC) technique for assay and identification of OB and FFD, as well as identification and estimate of its associated compounds in pressurized metered dose inhaler product (pMDI). Separation of oxitropium and formoterol peaks were enhanced on a C18 (50 × 2.1 mm × 1.7 μm) UPLC column with ethylene-bridged-hybrid technology, The mobile phase consists of buffer (0.07 M KH2PO4) and acetonitrile (80:20, v/v). The detector wavelength of 210 nm, flow rate of pump 0.6 mL/min, and oven temperature for column were set at 25°C. The injection volume was 10 μL. The method run time was 2 min. The mobile phase was used as the solvent. Retention times (RTs) were 0.5 min for OB and 1.0 min for FFD. The assay analysis was linear range for all analytes within the range for concentrations 0.03-14.8 µg/mL of OB, 0.01-0.88 µg/mL of FFD. LOD values and LOQ values 0.009 and 0.026 µg/mL for OB and 0.003 and 0.009 µg/mL for FFD, respectively. Recoveries were obtained at 96.3% for OB and 97.2% for FFD. Precisions values were (as RSD, %) ≤1.5%. With the UPLC method developed and validated according to the current ICH guidelines, it is possible to simultaneously detect OB and FFD of assay analysis in pMDI products accurately, precisely and selectively, independent of the matrix effect. The present method is the first method in the literature based on the UPLC method for this purpose. The UPLC method is a time-saving method, it provides a faster and cheaper technique than the high performance liquid chromatography (HPLC) method.

IBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products.

In this article, we specify for the first time a quantitative biopharmaceutics classification system for orally inhaled drugs. To date, orally inhaled drug product developers have lacked a biopharmaceutics classification system like the one developed to navigate the development of immediate release of oral medicines. Guideposts for respiratory drug discovery chemists and inhalation product formulators have been elusive and difficult to identify due to the complexity of pulmonary physiology, the intricacies of drug deposition and disposition in the lungs, and the influence of the inhalation delivery device used to deliver the drug as a respirable aerosol. The development of an inhalation biopharmaceutics classification system (iBCS) was an initiative supported by the Product Quality Research Institute (PQRI). The goal of the PQRI iBCS working group was to generate a qualitative biopharmaceutics classification system that can be utilized by inhalation scientists as a "rule of thumb" to identify desirable molecular properties and recognize and manage CMC product development risks based on physicochemical properties of the drug and the deposited lung dose. Herein, we define the iBCS classes quantitatively according to the dose number and permeability. The proposed iBCS was evaluated for its ability to categorize marketed inhaled drugs using data from the literature. The appropriateness of the classification of each drug was assessed based on published development, clinical and nonclinical data, and mechanistic physiologically based biopharmaceutics modeling. The inhaled drug product development challenges for each iBCS classification are discussed and illustrated for different classes of marketed inhaled drugs. Finally, it is recognized that discriminatory laboratory methods to characterize regional lung deposition, dissolution, and permeability will be key to fully realizing the benefits of an iBCS to streamline and derisk inhaled drug development.

Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part II-Quantification of the Test Uncertainty Ratio for Pass/Fail Decision-Making under Pharmacopeial Constraints.

Background: The pressure drop at any cascade impactor stage is related to the open area of nozzles at that stage. Pressure drop measurement therefore can potentially test whether the nozzles of a given stage are within the range specified for continued use for testing of inhalable drug products. Previous such efforts, however, have been hindered by the measurement precision required for making a pass/fail decision about these used impactors. In this study, we articulate the error analysis for a pressure drop measurement system managed with a critical flow venturi (CFV) and show that the resultant uncertainty in the effective diameter of used Next Generation Impactor (NGI) and Andersen-type impactor stages is generally small compared to the specification range. This result enables the user to make a pass/fail decision regarding suitability for continued use. Methods: We develop the equations governing the relationship between stage pressure drop and the effective diameter of each stage of a used impactor. These equations show that pressure drop measurements can indicate only the change (if any) in the effective diameter between a previous measurement and the current measurement. Propagation-of-error principles therefore show that the uncertainty of both measurements affects the resulting uncertainty. Results: The test uncertainty ratio (analytical power) of a CFV-managed pressure drop measurement system exceeds six for all but stage one of the NGI and for stages -1 and -2 of the Andersen-type impactor. The stage-one nozzle of the NGI is readily qualified with a Class X pin. Conclusions: The CFV-managed flow system described in Part I is sufficiently precise to enable a decision to be made about whether used impactor nozzles are suitable for continued use for testing of registered inhalable drug products. Examination of the industrial viability of the technology will require long-term testing in real-world settings with comparison to optical inspection methods.

Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part I-Laboratory Proof-of-Principle.

Background: Cascade impactors are essential for measuring the aerodynamic particle size distribution delivered by metered dose, dry powder, and similar inhalable drug products. For quality control of used impactors, periodic optical inspection of the nozzles of each impactor stage (stage mensuration) is currently the only method sufficiently precise to test whether used impactors are suitable for continued use, in accord with pharmacopeial standards. Here, we demonstrate a new method for quality control of used impactors. The method combines stage-wise pressure-drop measurement with a critical flow venturi (CFV) for air flow management. This technique avoids the unacceptably large uncertainty in conventional air flow rate measurements and instead relies on pressure and temperature measurement upstream of the CFV. These measurements can be made precisely with affordable equipment. Methods: We placed a toroidally shaped CFV downstream of a Next Generation Impactor™** (NGI) and precisely measured the stagnation pressure (±0.02%) and temperature (±0.03%) upstream of this CFV at impactor inlet flow rates close to 60 L/min. Pressure-drop measurements (±0.25%) at stages 3-7 and the micro-orifice collector were made with capacitive diaphragm transducers and with a special lid to the NGI that allowed pneumatic connection to the interstage passageways before and after each impactor stage. Results: The measured pressure drop values matched, to fractional percentage precision, those predicted by the incompressible flow theory through the nozzles and the compressible flow theory through the CFV. Conclusions: Practical equipment has been assembled that measures, to fractional percentage precision, the pressure drop through impactor nozzles at precisely managed flow conditions. The experimental results support the relevant flow principles. The results, thereby, support the use of this method for quantifying whether used impactor stages are suitable for continued use in the testing of registered inhalable drug products, in accord with pharmacopeial standards.

Dry Powder Inhalers: An Overview.

Dry powder inhaler products have played an important role in the treatment and prevention of asthma and more recently chronic obstructive pulmonary disease. The considerations that go into formulation development to support these products cover a unique range of disciplines including analytical and physical chemistry, aerosol physics, device technology, process engineering and industrial design. An enormous research effort has been expended in the last half century to provide understanding of this complex dosage form. The guiding principles in considering the development of dry powder inhaler products encompass requirements for disease therapy, advantages and limitations of adopting certain technological approaches, and desirable features to facilitate patient use, which are all embodied in the target product profile.

A U.S. Food and Drug Administration perspective on cannabis research and drug development

Since the early 1970s, the U.S. Food and Drug Administration (FDA) has received over 800 investigational new drug applications (INDs) for, and pre-INDs pertaining to, research of cannabis or cannabis-derived products. The current data show that applications for research of these products submitted by both academic researchers and commercial developers focus on four major clinical areas: addiction and pain medicine (53%), neurology (19%), immunology and inflammation (14%), and psychiatry (9%). The product types studied have expanded greatly in recent years and include a wide variety of topical, inhalable, injectable, and oral products. In this article, the authors present a breakdown of cannabis and cannabis-derived applications received by the FDA over the past 50 years. The authors also provide a summary of their experience and challenges in reviewing applications for research of cannabis and cannabis-derived products, as well as recommendations for those interested in studying cannabis and cannabis-derived products in human clinical trials. This perspective article includes a discussion on important IND criteria, the pre-IND consultation program, drug master files (DMFs), and various guidance documents and resources. Lastly, the authors provide their perspective for the future of cannabis drug development.

Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)

Although nasal inhalation products are becoming more and more important for the delivery of medicines, characterization of these products for quality control and assessment of bioequivalence is complicated. Most of the problems encountered are associated with the assessment of aerodynamic droplet/particle size distribution (APSD). The droplets produced by the various nasal devices are large, and for suspension products, individual droplets may contain multiple drug particles or none at all. Assessment of suspension products is further complicated by the presence of solid excipient particles. These complications make it imperative that the limitations of the instruments used for characterization as well as the underlying assumptions that govern the interpretation of data produced by these instruments are understood. In this paper, we describe various methodologies used to assess APSD for nasal inhalation products and discuss proper use, limitations, and new methodologies on the horizon.