NEW DRY POWDER COMPOSITION FOR PERORAL ADMINISTRATION.

Abstract

According to the invention, a pharmaceutical dosage form suitable for peroral administration into the gastrointestinal tract is provided. This dosage form comprises a pharmaceutical composition in the form of a particulate mixture comprising solid particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (C21), or a pharmaceutically acceptable salt thereof, mixed with a mixture of carrier particles having a weight- and / or volume-based mean diameter and / or structural / particle density similar to the weight- and / or volume-based mean diameter and / or structural / particle density of the solid C21 particles, and a glide. This composition is contained within a capsule suitable for peroral administration. The preferred carrier particles have a weight- and / or volume-based mean diameter of less than approximately 100 µm.Preferred carrier materials include mannitol. Preferred glides comprise colloidal silica. Such dosage forms are useful in the treatment of pulmonary diseases, such as idiopathic pulmonary fibrosis, sarcoidosis, and tissue damage induced by respiratory viruses.

Description

NEW DRY POWDER COMPOSITION FOR PERORAL ADMINISTRATION Field of invention This invention relates to new forms of pharmaceutical dosage, their use as medicines, and particularly their administration to treat, among other things, pulmonary diseases, for example, interstitial lung diseases. Background and previous technique Interstitial lung diseases (ILDs) are a group of lung diseases that affect the interstitium and are characterized by scarring and / or thickening of the tissue around the alveoli, which inhibits the respiratory process. ILDs are distinct from obstructive airway diseases (e.g., chronic obstructive pulmonary disease [COPD] and asthma), which are generally characterized by narrowing (obstruction) of the bronchi and / or bronchioles. ILDs can be caused by injury to the lungs, which triggers an abnormal healing response, but in some cases, these diseases have no known cause. ILDs can be triggered by chemicals (silicosis, asbestosis, certain drugs), infections (e.g., pneumonia), or other diseases (e.g., rheumatoid arthritis, systemic sclerosis, myositis, hypersensitivity pneumonitis, or systemic lupus erythematosus). The most common ILDs are idiopathic pulmonary fibrosis (IPF) and sarcoidosis, both characterized by chronic inflammation and reduced lung function. Sarcoidosis is a disease of unknown cause characterized by clusters of inflammatory cells that form lumps (granulomas), often starting in the lungs (as well as the skin and / or lymph nodes, although any organ can be affected). When sarcoidosis affects the lungs, symptoms include cough, wheezing, shortness of breath, and / or chest pain. Treatments for sarcoidosis are specific to each patient. In most cases, symptomatic treatment with medication is possible. Q / ZLQn / ZZnZ / 3 / YILI non-steroidal anti-inflammatory drugs (NSAIDs) are used, but for those with pulmonary symptoms, glucocorticoids (e.g., prednisone or prednisolone), antimetabolites, and / or monoclonal antibodies against tumor necrosis factor are often used. IPF is a lung disease of unknown cause that affects approximately 5 million people worldwide. There are no curative treatment options except, in rare cases, lung transplantation, which results in chronic, irreversible, and progressive decline in lung function and, in most cases, leads to death within 2–5 years (median survival 2.5–3.5 years). While the overall prognosis for IPF is poor, it is difficult to predict the rate of progression in individual patients. Risk factors for IPF include age, male sex, genetic predisposition, and a history of smoking. The annual incidence is 5-16 per 100,000 people, with a prevalence of 13 to 20 cases per 100,000 people, which increases dramatically with age (King JrTE et al., Lancet (2011) 378, 1949-1961; Noble PW et al., J. Clin. Invest. (2012) 122, 2756-2762).IPF is confined to the lungs and is resistant to therapies that target the immune system, distinguishing it from pulmonary fibrosis (PF) associated with systemic diseases. Patients with IPF typically seek medical attention due to chronic, progressive cough and exertional dyspnea. Lung imaging classically reveals traction bronchiectasis, thickened interlobular septa, and subpleural honeycombing. When all three manifestations are present and there is no evidence of systemic connective tissue disease or environmental exposure, a diagnosis of IPF is highly likely. A definitive diagnosis is usually made by lung biopsy and requires an experienced multidisciplinary team, including pulmonologists, radiologists, and pathologists with expertise in ILD. IPF presents with different phenotypes and prognoses, defined as mild, moderate, and severe. Mild cases follow a stable or slow, progressive course, and patients sometimes take several years to seek medical advice. Accelerated IPF has a much more rapid progression with shorter survival and affects a subgroup of patients, generally male smokers. Acute exacerbations of IPF are Q / ZLQn / ZZnZ / 3 / YILI defines it as a rapid worsening of the disease, and patients in this subpopulation have a poor clinical outcome with a high short-term mortality rate. The cause of IPF is unknown, but it appears to be a disorder that likely arises from an interaction of environmental and genetic factors resulting in continuous fibroblast-directed tissue remodeling rather than normal repair; a pathogenesis driven primarily by fibrosis rather than inflammation. A growing body of evidence suggests that the disease is initiated by microlesions of alveolar epithelial cells and apoptosis, which activate neighboring epithelial cells and attract stem or progenitor cells that produce the factors responsible for the tumor-like expansion of fibroblast and myofibroblast populations.Fibroblastic foci secrete excessive amounts of extracellular matrix that destroys lung parenchyma and ultimately leads to loss of lung function. The mean annual rate of decline in lung function (vital capacity) is within a range of 0.13 to 0.21 liters. Symptoms precede diagnosis by 1 to 2 years, and radiographic signs may precede symptoms (Ley B et al., Am. J. Respir. Crit. Care Med. (2011) 183, 431-440). Numerous treatment approaches have been tested in preclinical models and clinical trials, including anti-inflammatory, immunomodulatory, cytotoxic, antifibrotic agents in general, antioxidant, anticoagulant, antichemical and antiangiogenic agents, as well as RAS blockers, endothelin antagonists and sildenafil, all of which have basically been shown to provide limited or no benefit (Rafii R et al., J. Thorac. Dis. (2013) 5, 4873). Current treatment for IPF includes oxygen supplementation. Medications used include pirfenidone or nintedanib, but these have had only limited success in slowing disease progression. Furthermore, both drugs commonly cause side effects (predominantly gastrointestinal). There are drawbacks associated with all of the above-mentioned drug treatments for ILD (and IPF), and there is a real clinical need for safer and / or more effective treatments. Restoring the alveolar epithelium is very convenient as a therapeutic effect in the Q / ZLQn / ZZnZ / 3 / YILI IPF, so stem cell therapy has also been tested. Some preclinical studies have shown promise in the use of pluripotent stem cells that can differentiate into pulmonary epithelial and endothelial cells, thereby repairing lung injury and fibrosis. Currently, lung transplantation is the only intervention that substantially improves survival for patients with IPF. However, complications such as infections and transplant rejection are not uncommon. Therefore, the development of new treatment strategies for IPF is important. Thus, the fundamental challenge for the future is to develop appropriate therapeutic approaches that reverse or halt the progression of the disease. The renin-angiotensin system (RAS) is a key regulator of blood pressure homeostasis. Renin, a protease, cleaves its only known substrate (angiotensinogen) to form angiotensin I (Ang I), which in turn serves as a substrate for angiotensin-converting enzyme (ACE) to form Ang II. The endogenous hormone Ang II is a linear octapeptide (Asp1-Arg2-Val3-Tyr4-Ile5-His6-Pro7-Phe8) and is an active component of the renin-angiotensin system (RAS). The angiotensin II type 1 (AT1) receptor is expressed in most organs and is believed to be responsible for most of the pathological effects of Ang II. The safety and efficacy of losartan (an ATL receptor inhibitor) has recently been investigated in a small, open-label, uncontrolled pilot trial on IPFI (www.clinicaltrials.gov, identifier NCT00879879). Several studies in adult individuals appear to demonstrate that, in modulating the response after Ang II stimulation, activation of the angiotensin II type 1 receptor (AT2) has effects opposite to those mediated by the AT1 receptor. The AT2 receptor has also been shown to be involved in apoptosis and inhibition of cell proliferation (de Gasparo M et al., Pharmacol. 1st 2nd 2nd 2nd 2nd 2nd 3rd 2nd 3rd 2nd 3rd 3rd 4th ...4th 3rd 4th 5th 4th 2nd 3rd 4th 5th 6th 4th 5th 6th AT2 receptor agonists have also been shown to have potential utility in the treatment and / or prophylaxis of digestive tract disorders, such as dyspepsia and irritable bowel syndrome, as well as insufficiency. Q / ZLQn / ZZnZ / 3 / YILI multi-organic (see international patent application no. WO 99 / 43339). The expected pharmacological effects of AT2 receptor agonism are generally described in de Gasparo M et al., supra. It is not mentioned that AT2 receptor agonism can be used to treat IPF. International patent application WO 2002 / 096883 describes the preparation of imidazolyl, triazolyl, and tetrazolyl thiophenesulfonamides and derivatives as AT2 receptor agonists. Among the compounds described therein (as Example 1) is N-butyloxycarbonyl-3-(4-imidazol-111methylphenyl)-5-iso-butylthiophen-2-sulfonamide (Compound 21, or C21 hereafter), which was selected for clinical development from a group of approximately 20 related analogues as a selective AT2 receptor agonist. C21 is now in clinical development for the treatment of AT2 receptor-related disorders in which treatment with an AT2 receptor agonist is believed to be beneficial, including IPF (see, for example, International patent application WO 2016 / 139475). The formulation work carried out with respect to C21 and its salts has proven extremely difficult. Part of the problem is the previously unreported extreme sensitivity of C21 and its salts to the combined presence of light and water. Furthermore, attempts to provide stable, even dry, solid-state formulations have resulted in mixtures with conventional excipients that are chemically unstable. This information has not been previously made publicly available. As a result, C21 has been previously formulated as an aqueous solution, which is frozen during storage and then thawed immediately before oral dosing. Protecting C21 in this manner from light-catalyzed aqueous decomposition presents logistical challenges for shipping pharmaceuticals worldwide. A more stable, pharmaceutically acceptable composition is highly desirable, if not a requirement, for a commercially viable product. The applicant has been working with this active ingredient for almost 20 years and, until recently, had not been able to obtain a pharmaceutically acceptable dosage form, i.e., one in which the active ingredient is stable when stored at room temperature. Q / ZLQn / ZZnZ / 3 / ΥΙΛΙ reproducible form. In attempting to prepare such an improved dosage form based on oral capsules, the applicant has discovered that it is possible to resolve the above problems by dry mixing with a specific combination of excipients, in a specific manner, as described below. Description of the invention According to a first aspect of the invention, a pharmaceutical dosage form suitable for peroral administration into the gastrointestinal tract is provided. This dosage form comprises a pharmaceutical composition in the form of a particulate mixture comprising solid particles of C21, or a pharmaceutically acceptable salt thereof, mixed with a mixture of carrier particles having a weight- and / or volume-based mean diameter and / or particle density (structural) similar to the weight- and / or volume-based mean diameter and / or particle density (structural), respectively, of the solid particles of C21, or a pharmaceutically acceptable salt thereof, and a glide, the composition of which is contained within a capsule suitable for such peroral administration. These dosage forms are hereinafter collectively referred to as the dosage forms of the invention. The dosage forms of the invention are suitable for oral administration and delivery, as a complete dosage form, to the gastrointestinal tract. This means that a dosage form of the invention must be suitable for being swallowed as a whole and complete dosage form for subsequent consumption and / or ingestion within the gastrointestinal tract, and, in use, is swallowed and then consumed and / or ingested within said tract. Appropriate pharmaceutically acceptable capsules include hard or soft shell capsules, which may be made of gelatin, cellulose polymers, for example hydroxypropyl methylcellulose (HPMC or hypromellose), hypromellose acetate succinate (HPMCAS), starch polymers, pullulan, or other suitable materials, for example by means of standard capsule filling processes. Q / ZLQn / ZZnZ / 3 / YILI However, we prefer that the capsules be two-piece, hard-shelled capsules, for example, capsules made of gelatin or, more preferably, HPMC, supplied as sealed halves that can be separated, filled with particulate material, and then reassembled. Such capsules can be of any size (for example, from 00 to 5), but the preferred capsule sizes are size 2, size 1, or, more preferably, size 0. It is further preferred that the pharmaceutical composition of the dosage form of the invention, which is contained within a capsule as described above, be manufactured and / or stored in such a way as to remain essentially free of water. By essentially water-free, we include that appropriate precautions are taken to ensure that both the C21 particles or a salt thereof, and the essential excipient particles with which it is mixed, are individually prepared and / or supplied in such a way that they are essentially dry, and are also mixed together to form a dry mixture in an environment in which they are kept essentially dry. By essentially dry or essentially water-free, we mean that the composition comprising C21 / salt and essential excipients comprises, in its entirety, no more than approximately 5%, including no more than 2%, as no more than 1%, including no more than 0.5%, as approximately 0.1% water or less. The dosage form compositions of the invention comprising C21 or a salt thereof and essential excipients as defined above can, once prepared, be subsequently loaded into capsules. Given that such compositions are preferably prepared in an essentially water-free state, such loading is also preferably carried out in such a manner as to maintain them in that state. In this respect, although pharmaceutically acceptable capsule materials may contain a residual amount of water, the entry of water into the composition from the capsule material should be minimized, thereby protecting the highly sensitive C21 or a salt thereof from contact with water and, therefore, in the presence of light, from degradation. Q / ZLQn / ZZnZ / 3 / YILI However, it is preferable (though not necessarily essential) to package the dosage forms of the invention in such a way that the dosage form itself remains dry and protected from light. This may include airtight packaging, the use of deliquescent materials, etc. C21 or a salt thereof occurs in the form of particles, which may be amorphous, crystalline, or a mixture of both. Preferred particles are of a size that will not result in segregation, either during the formation of the composition to be loaded into the capsules, during the capsule loading process, or during storage. In this regard, C21 or a salt thereof may be provided in the form of a plurality of primary (i.e., non-agglomerated) particles that typically have a weight- and / or volume-based mean diameter of no more than approximately 1000 pm, such as approximately 500 μm, including approximately 250 pm, preferably no more than approximately 100 pm, including no more than approximately 50 pm, such as approximately 20 pm, or no more than approximately 10 pm. Although there is no lower limit on the particle size that may be employed according to the invention, for ease of manufacture, we prefer that the primary particles of C21 or a salt thereof have a weight- and / or volume-based mean diameter of no less than approximately 1 pm, such as approximately 2 pm, including approximately 3 pm. As used in this document, the term weight-based mean diameter shall be understood by those skilled in the art to mean that the mean particle size is characterized and defined from a weight particle size distribution, i.e., a distribution where the existing fraction (relative amount) in each size class is defined as the weight fraction, as obtained, for example, by sieving (e.g., wet sieving). The term volume-based mean diameter is similar in meaning to weight-based mean diameter, but those skilled in the art shall understand that it means the mean particle size is characterized and defined from a volume particle size distribution, i.e., a distribution where the existing fraction (relative amount) in each size class is defined as the volume fraction, as measured, for example, by laser diffraction. Particle sizes Q / ZLQn / ZZnZ / 3 / YILI can also be measured using standard equipment, such as a dry particle size measurement technique, including dry dispersion technologies available from manufacturers like Sympatec GmbH (Clausthal-Zellerfeld, Germany). Other instruments well-known in the field for particle size measurement can be employed, such as equipment sold by, for example, Malvern Instruments, Ltd. (Worcestershire, UK), Shimadzu (Kyoto, Japan), and Elzone, Micromeritics (USA; electrical detection zone method). By particles having average diameters based on weight and / or volume within the above limits, we include the average diameters of the particles when prepared and before mixing with the essential excipients according to the invention, and / or before loading into the capsules. It will be appreciated that some aggregation of primary particles to form secondary particles may occur during handling and / or processing of the active ingredient. However, this should be minimized. O21 or a salt thereof may also be provided in the form of particles with a relatively narrow particle size distribution (PSD), measured using standard techniques and parameters accepted in the art, including the mass mean diameter (D50; the log-normal mass mean diameter), the mass mean particle size, and / or the diameter at which 50% of the mass in the cumulative PSD is contained, and / or the geometric standard deviation (GSD or ag, as measured by the formula D84.13 / D50 or D50 / D15.78, where D84.13 and D15.78 are respectively the diameters at which 84.13% and 15.78% of the mass are contained, and D50 is as defined above). Such parameters may be measured and calculated in the process using any appropriate sampling method and particle size measurement technique as described above. In this respect, it is preferred that C21 or a salt thereof have a PSD with a GSD that is less than approximately 4, such as less than approximately 3. Primary particles of O21 or a salt thereof can be prepared by a suitable technique, such as precipitation, shearing (e.g., by dissolution in a supercritical fluid under pressure, followed by rapid expansion), spray drying, or can, where appropriate, be micronized. Q / ZLQn / ZZnZ / 3 / YILI using techniques well known to experts in the art, such as grinding, dry grinding, jet grinding, wet grinding and / or crushing. The particles can also be screened to separate them into a fraction of the desired size and / or to break up agglomerates and / or remove fine material. In either case, undersized (fine) and oversized unused material can be reprocessed to avoid waste. Alternatively, the particles can be separated into appropriate particle sizes using cyclone separation, air classifier, sedimentation, force field fractionation, and / or elutriation. Although C21 or a salt thereof may be selected and / or provided with the weight or volume-based average diameters, particle sizes, PSD and / or GSD mentioned above using one or more of the above techniques, one of the main benefits of formulating the compositions to be loaded into capsules to form dosage forms of the invention is that C21 or a salt thereof does not require the particle processing techniques described above prior to mixing with the essential excipients. As mentioned previously, we have found C21 and its salts to be extremely difficult materials to work with. In particular, and as described below, compatibility studies have revealed that certain standard excipients, when mixed with C21 and its salts, result in significant chemical instability of the active ingredient. Furthermore, C21 and its salts form needle-like crystals that are sticky and prone to agglomeration. This means that dry blending with other pharmaceutically acceptable standard ingredients is very difficult, and it is not straightforward to produce blends with pharmaceutically acceptable active ingredient content uniformities and / or uniform dosages within the capsules. Furthermore, as described below, micronization of primary active ingredient particles has also failed to provide a solution to these problems, as the expert in the technique might have expected, and has also been found to give rise to additional problems related to heating and static electricity. Q / ZLQn / ZZnZ / 3 / YILI However, we have found that mixing C21 or a pharmaceutically acceptable salt of it with a premixed mixture of: (a) carrier particles having a weight- and / or volume-based mean diameter that is approximately the same dimension as the C21 / salt particles, and (b) a slip, it is possible to avoid the aforementioned problems and provide a composition for loading into capsules in which the C21 or a salt thereof is not only homogeneously and uniformly distributed, ensuring the homogeneity of the active ingredient dosage between the capsules after such loading, but is also physically and chemically stable, during and / or after manufacturing, under normal storage conditions and / or during use. The terms homogeneous and homogeneously distributed in the context of the invention mean that there is a substantially uniform content of C21 or a salt thereof throughout the carrier material (and / or other excipients employed). In other words, if multiple samples (e.g., at least 2, more preferably about 6, such as about 10 up to about 30 or more if necessary) are taken from a mixture comprising the active ingredient and the carrier mixture, the measured content of active ingredient present among such samples results in a standard deviation from the mean amount (i.e., the coefficient of variation and / or the relative standard deviation) of less than 8%, such as less than 6%, for example, less than 5%, particularly less than about 4%, for example, less than about 3%, and preferably less than about 2%. Therefore, according to the invention, C21 or a pharmaceutically acceptable salt thereof can be prepared and stored in the form of a composition that can be directly loaded into capsules to prepare a dosage form of the invention, and furthermore, once prepared, the dosage forms of the invention can be stored under normal storage conditions with a negligible degree of change in the physicochemical properties of the dosage form, the mixture of Q / ZLQn / ZZnZ / 3 / YILI composition contained in this and / or, more importantly, the active ingredient, over time. A negligible degree of change in physicochemical properties is therefore included, that compositions comprising C21 / salt mixed with the essential excipients as described above, before and after being loaded into capsules (i.e., in the form of a dosage form of the invention), possess physical stability and chemical stability. For chemical stability, we include that the dry mixture compositions comprising C21 / salt and essential excipients of the invention, and the dosage forms of the invention, can be stored (with or without appropriate pharmaceutical packaging), under normal storage conditions, with a negligible degree of chemical degradation or decomposition of the dosage forms of the invention, of the dry mixtures containing them, and in particular, of the active ingredient. By physical stability, we include that the dry mixture compositions comprising O21 / salt and essential excipients of the invention, and the dosage forms of the invention, can be stored (with or without appropriate pharmaceutical packaging), under normal storage conditions, with a negligible degree of physical transformation, such as aggregation, separation or segregation, and / or changes in the nature and / or integrity of the dosage forms of the invention, the dry mixtures containing them and, in particular, the active ingredient, including solid-state phase transition, etc. Examples of normal storage conditions include temperatures between -80 and over 50°C (preferably between 0 and 40°C and, more preferably, room temperature, such as between 15 and 30°C), pressures between 0.1 and 2 bar (preferably atmospheric pressure), relative humidities between 5 and 95% (preferably 10 to 60%), and / or exposure to 460 lux of UV / visible light, for extended periods (i.e., greater than or equal to six months). Under such conditions, C21, its salt, and / or dry mixture compositions containing them, may be found with less than approximately 15%, more preferably less than approximately 10%, and especially less than approximately 5%, when physically and / or chemically transformed as defined above. Those skilled in the art will appreciate that the limits The above-mentioned upper and lower Q / ZLQn / ZZnZ / 3 / YILI values ​​for temperature and pressure represent the extremes of normal storage conditions, and that certain combinations of these extremes will not be experienced during normal storage (e.g., a temperature of 50°C and a pressure of 0.1 bar). The essential excipients that are mixed with C21 particles or a pharmaceutically acceptable salt thereof comprise a mixture of carrier particles with a weight- and / or volume-based mean diameter that is approximately the same as that of the C21 / salt particles, and a gluent. Suitable carrier particle materials may comprise pharmaceutically acceptable substances that are water-soluble, such as carbohydrates, for example, sugars such as lactose, and sugar alcohols such as mannitol, sorbitol, and xylitol; or pharmaceutically acceptable inorganic salts such as sodium chloride. Alternatively, the carrier particles may comprise pharmaceutically acceptable substances that are insoluble or sparingly soluble in water, such as microcrystalline cellulose, anhydrous dicalcium phosphate, dicalcium phosphate dihydrate, tricalcium phosphate, calcium carbonate, and barium sulfate; starch and pregelatinized starch.Preferred carrier particle materials include carbohydrates, including sugar alcohols such as sorbitol, xylitol, and, in particular, mannitol. Carrier particles may comprise physical mixtures of any of these materials and / or may comprise composites of one or more of these materials. The carrier particles have a particle size distribution and / or structural (particle) density similar to that of the active ingredient particles used in compositions that are loaded into capsules to prepare dosage forms of the invention. By similar structural particle size distribution and / or density (of particles) we mean that the weight and / or volume-based mean diameter and / or particle density of the carrier particles is within approximately ±75%, such as approximately ±50%, including approximately ±40%, for example, approximately ±30%, or approximately ±20% including approximately ±10% of the relevant dimensions of C21 or a salt thereof being employed. Q / ZLQn / ZZnZ / 3 / YILI In this regard, preferred carrier particle sizes include a weight and / or volume-based mean diameter that is less than approximately 100 pm, including less than approximately 80 pm, such as less than approximately 70 pm, for example, between approximately 20 pm and approximately 60 pm (for example, approximately 25 pm or, more preferably, approximately 50 pm). We have found that, by using carrier particles with sizes similar to those of the active ingredient and / or within the above ranges, segregation of the mixture is avoided. To make dry mix compositions that are loaded into capsules to make dosage forms of the invention, before mixing with the active ingredient, carrier particles of the required size are premixed with a suitable slip material. A slip material is a pharmaceutically acceptable material that will promote powder flow by reducing friction and / or cohesion between particles (but does not necessarily have the ability to reduce and / or prevent adhesion to external materials, such as capsule filling machines or hoppers). Suitable pharmaceutically acceptable slip materials include talc, magnesium carbonate, or calcium silicate, although a hydrophilic slip material is preferred, such as one or more of the various forms of silica, including silica gels, silica aerogels, or, more particularly, a proprietary silica produced under the registered trademark Syloíd® (see https: / / grace.com / pharma-and-biotech / en-us / Documents / Syloid / M309c), a colloidal silica and / or fumed / pyrogenic silica. Preferred forms of silica therefore include stable aqueous dispersions (sols) of amorphous silica particles with a weight- and / or volume-based mean diameter that is between approximately 1 nm and approximately 100 nm (e.g., up to approximately 50 nm, such as up to approximately 20 nm, such as between approximately 10 nm and approximately 15 nm). Therefore, it is preferred that the slip and carrier particles be mixed to form an interactive (or ordered) mixture of carrier particles that are largely coated with smaller particles of a slip material; this mixture is then blended with active ingredient particles. We have also found that adding the aforementioned slip to Q / ZLQn / ZZnZ / 3 / YILI carrier particles to first form a mixture of excipients, before mixing it with the active ingredient, improve the flow properties of that mixture of excipients, and thus subsequently achieve a better mixture with C21 or a pharmaceutically acceptable salt of it, also decreasing the probability of segregation of the mixture. The dosage forms of the invention may also include other excipients well known to those skilled in the art for the oral administration of active ingredients. Therefore, other excipients, if necessary, may be added to the powder mixture according to the invention, such as colorants, antioxidants, which may be natural or synthetic (e.g., butylated hydroxytoluene (BHT), vitamin C, vitamin E, β-carotene, uric acid, unichion, superoxide dismutase (SOD), glutathione peroxidase, or catalase peroxidase), preservatives, and disintegrants, including those described, for example, in Rowe et al., Handbook of Pharmaceutical Excipients, 8th ed. (2017). However, in view of the extreme sensitivity of C21 and its salts to other chemicals, it is preferred that such other excipients not be included in the dosage forms of the invention. In this regard, a dosage form of the invention is provided, consisting essentially of a pharmaceutical composition in the form of a particulate mixture comprising solid particles of C21, or a pharmaceutically acceptable salt thereof, mixed with a mixture of carrier particles having a weight- and / or volume-based mean diameter and / or particle density (structural) that is / are similar to the weight- and / or volume-based mean diameter and / or particle density (structural) of the solid particles of C21, or a pharmaceutically acceptable salt thereof (as defined above), and a glide. This composition is contained within a capsule suitable for oral administration.All preferred features mentioned herein for other aspects of the invention that are in any way related to this aspect of the invention are equally applicable. The expression consisting essentially of shall be understood to mean that the scope of this (and only this) aspect of the invention is limited to the essential features specified above, together with other features that do not materially affect the feature or Q / ZLQn / ZZnZ / 3 / YILI basic and novel features of this aspect of the invention. In this regard, although not an essential feature of the invention, it may be preferable to add a lubricant (such as sodium stearyl fumarate or, preferably, magnesium stearate) to the mixture before filling into capsules to prevent the mixture from adhering to the equipment (e.g., capsule filling machines and hoppers). This is a preferred feature that does not materially affect the basic and novel features of this aspect of the invention. Alternatively, compositions to be loaded into a capsule consisting essentially of a mixture of particles comprising solid particles of C21, or a pharmaceutically acceptable salt thereof, mixed with the carrier particle mixture and the glide, may mean that the composition comprises at least approximately 95%, such as at least approximately 97% by weight, of those particular ingredients in total. Furthermore, the dosage forms of the invention may also impart, or may be modified to impart, an immediate, or modified, release of active ingredient or ingredients. Additional excipients may be commercially available or described in the literature, for example, Remington The Science and Practice of Pharmacy, 21st ed., Lippincott Williams and Wilkins, Philadelphia (2006) and the documents referenced therein, the relevant descriptions of which are hereby incorporated by reference. Otherwise, the preparation of suitable oral formulations can be carried out in a non-inventive manner by the skilled using routine techniques. Preferred mixing equipment includes standard mixing equipment such as drum mixers, agitators (e.g., Turbula), convective mixers, hopper mixers, and fluidized bed mixers. Preferred mixers include V-mixers. According to a further aspect of the invention, a process is provided for the production of a dosage form of the invention, said process comprising: (a) mixing the carrier particles as defined above and the slide; Q / ZLQn / ZZnZ / 3 / YILI (b) mixing the mixture from step (a) with the C21 particles or a pharmaceutically acceptable salt thereof; and (c) loading the mixture from step (b) into a capsule suitable for peroral administration. It is preferable that the dry mix be passed through a sieve at points during the mixing process to break up any agglomerates that form, for example, as described below. A suitable sieve is one that has a pore size as small as (or approximately small as) the particle size of the largest component in the mix. Therefore, suitable sieve sizes range from approximately 50 µm (e.g., 75 µm), including 100 µm, such as 150 µm, 200 µm, or 250 µm (e.g., approximately 300 µm), up to approximately 1000 µm (e.g., approximately 400 µm, or approximately 500 µm), up to approximately 900 µm (e.g., approximately 800 µm). Pharmaceutically acceptable salts of C21 include acid addition salts. Such salts can be formed by conventional means, for example, by reacting C21 in the form of free acid (hereafter referred to as free C21) with one or more equivalents of a suitable acid, optionally in a solvent or in a medium in which the salt is insoluble, followed by removal of the solvent or medium using standard techniques (e.g., vacuum, freeze-drying, or filtration). Salts can also be prepared by exchanging a counterion of an active ingredient in the form of a salt with another counterion, for example, using a suitable ion-exchange resin. Preferred salts of C21 include HCl salts, alkaline earth salts such as magnesium and calcium salts, and alkali metal salts such as potassium or, preferably, sodium salts. The amount of C21 or a salt thereof in a dosage form of the invention will depend on, and / or may be selected based on, the severity of the condition, or the expected severity thereof, as well as the patient to be treated, but may be determined by a person skilled in the art. The mode of administration may also be determined by the timing and frequency of administration, as well as by the severity of the condition. The appropriate lower daily doses of C21 in adult patients (weight Q / ZLQn / ZZnZ / 3 / YILI (medium, for example, 70 kg) may be approximately 10 mg, such as approximately 20 mg, or approximately 25 mg, per day. Suitable upper limits of the daily dose ranges of C21 may be up to approximately 900 mg, such as approximately 600 mg, including approximately 400 mg and approximately 200 mg, or approximately 100 mg, including approximately 50 mg. All the above doses are calculated as free C21. The doses may be divided into multiple individual doses per day. The doses may be administered between one and six times, such as four times a day, preferably three times a day, and most preferably twice a day. In any case, the physician, or another expert, may routinely determine the actual dose, which will be the most appropriate for an individual patient, depending on the severity of the condition and the route of administration. The doses mentioned above are exemplary of the average case; of course, there may be individual cases that warrant higher or lower dosage intervals, which are within the scope of this invention. The dose administered to a patient, in the context of the present invention, must be sufficient to effect an appropriate response in the patient for a reasonable period (as described above). A person skilled in the art will recognize that the selection of the exact composition and dosage and the most suitable delivery regimen will be influenced, among other things, by the pharmacological properties of the formulation, the nature, stage, and / or severity of the condition to be treated, and the physical condition and mental acuity of the recipient, including the age, condition, body weight, sex, and response of the patient to be treated, the stage / severity of the disease, and genetic differences among patients. The dosage forms of the invention are useful under conditions in which AT2 receptors are expressed and their stimulation is desired or required. In this respect, the dosage forms of the invention are indicated in the treatment of conditions characterized by vasoconstriction, fibrosis, inflammation, increased cell growth and / or differentiation, increased cardiac contractility, increased cardiovascular hypertrophy and / or increased fluid and electrolyte retention, as well as skin disorders and Q / ZLQn / ZZnZ / 3 / YILI obstructive (such as chronic obstructive pulmonary disease), pneumonitis, pulmonary hypertension, and adult respiratory distress syndrome. Kidney disorders that may be mentioned include kidney failure, diabetic nephropathy, nephritis, and renal hypertension. Eye disorders that may be mentioned include diabetic retinopathy, premature retinopathy, and retinal microvascularization. Disorders of the female reproductive system that can be mentioned include ovulatory dysfunction and endometriosis. Cardiovascular disorders that may be mentioned include hypertension, cardiac hypertrophy, heart failure (including heart failure with preserved ejection fraction), arteriosclerosis, arterial thrombosis, venous thrombosis, endothelial dysfunction, endothelial injury, post-balloon dilation stenosis, angiogenesis, diabetic complications, microvascular dysfunction, angina, cardiac arrhythmias, intermittent claudication, preeclampsia, myocardial infarction, reinfarction, ischemic lesions, erectile dysfunction, and neointimal proliferation. Central nervous system disorders that may be mentioned include cognitive dysfunction, dysfunction of food intake (hunger / satiety) and thirst, stroke, cerebral hemorrhage, cerebral embolism and cerebral infarction, multiple sclerosis (MS), Alzheimer's disease, and Parkinson's disease. The dosage forms of the invention may also be useful in modulating growth and proliferation metabolism, for example, in the treatment of aging, hypertrophic disorders, prostate hyperplasia, autoimmune disorders (e.g., arthritis, such as rheumatoid arthritis or systemic lupus erythematosus), psoriasis, obesity, neuronal regeneration, ulcer healing, inhibition of adipose tissue hyperplasia, stem cell differentiation and proliferation, fibrotic disorders, cancer (e.g., in or of the gastrointestinal tract (including the esophagus or stomach), prostate, breast, liver, kidneys, as well as lymphatic cancer, lung cancer, ovarian cancer, pancreatic cancer, hematological neoplasms, etc.), apoptosis, tumors (in general) and hypertrophy, diabetes, neuronal injuries, and organ rejection. The dosage forms of the invention are also useful in the treatment Q / ZLQn / ZZnZ / 3 / YILI of stroke, spinal cord injury, sickle cell disease, muscular dystrophy, cancer treatment-related cardiotoxicity, peripheral neuropathy, and in particular, systemic sclerosis. Furthermore, the dosage forms of the invention may be useful in the treatment of tissue damage induced by respiratory viruses, such damage may include injury and / or dysfunction of relevant tissues. Relevant tissues include tissues (e.g., mucous membranes) of the respiratory tract, and especially those of the lung. Therefore, relevant tissue includes the respiratory epithelium, which moistens the airways and protects against the invasion of pathogens such as viruses. Respiratory viruses that may be mentioned in this regard include influenza viruses, such as influenza A virus (e.g., H1N1 and H3N2), influenza B virus, or influenza C virus), and, more particularly, coronaviruses, including severe acute respiratory syndrome (SARS) coronaviruses, such as SARS coronavirus (SARS-CoV), and in particular the novel SARS coronavirus 2 (SARS-CoV-2, formerly known as 2019nCoV or novel coronavirus 2019), which is the virus that causes coronavirus disease 2019 (COVID-19), of which there are many genetic variants. By treatment of tissue damage, we include that C21 and its salts can not only have a beneficial effect on tissue damage in the airways caused by said virus, but can also prevent and / or mitigate damage that would otherwise have been caused by that virus in the airways, which occurs when the relevant virus enters, for example, the epithelial cells of the airways. Therefore, C21 and salts can cancel or prevent the development of diseases caused by such virus-induced tissue damage and / or the symptoms of such damage or diseases. In this respect, C21 and its salts can treat and / or halt the progression of diseases that are or have been caused by respiratory viruses (i.e., diseases such as influenza, as well as acute lung injury (ALI), acute respiratory distress syndrome (ARDS), particularly SARS and, more specifically, COVID-19) and their sequelae. C21 and its salts can also treat and / or prevent damage that is, or has been, caused by such viruses, including the treatment and / or prevention of the symptoms of Q / ZLQn / ZZnZ / 3 / YILI such respiratory diseases, such symptoms include cough, dyspnea, respiratory distress (manifested, for example, by the need for supplemental / additional oxygen (which may be administered via a face mask or through a nasal cannula (high flow or otherwise)), and / or mechanical ventilation / extracorporeal membrane oxygenation), respiratory failure, and / or pneumonia, which may occur directly (viral pneumonia) and / or indirectly (bacterial pneumonia resulting from secondary bacterial infections, which is common in influenza), as well as the subsequent fibrosis resulting from inflammation in the lungs and other organs (for example, the heart and kidneys). In addition, C21 and salts thereof may prevent or halt the progression of respiratory virus-induced morbidity and / or mortality, and O21 may treat and / or halt the development of any of the chronic symptoms identified above. Furthermore, the dosage forms of the invention may also be useful in the treatment or prevention of any fibrotic condition of one or more internal organs characterized by the excessive accumulation of fibrous connective tissue, and / or in the treatment or prevention of fibrogenesis and the morbidity and mortality that may be associated with it. Such fibrosis may be associated with an acute inflammatory condition, such as acute respiratory distress syndrome (ARDS), SARS, and multi-organ inflammation, injury, and / or failure, which may be caused by internal or external trauma (e.g., an injury) or by infection. Therefore, such conditions can result from sepsis or septic shock caused by a viral, bacterial, or fungal infection. Furthermore, acute lung injury, ARDS, and particularly SARS can be caused by viruses, such as coronaviruses, including SARS-CoV-2, which can result in internal tissue damage and / or dysfunction of relevant internal tissues (e.g., mucous membranes) and / or the cells that compose them, such as the respiratory epithelium. This tissue damage can, in turn, lead to severe fibrosis. For example, SARS (coronavirus disease 2019 or COVID-19), caused by SARS-CoV-2, is known to result in fibrosis in many cases. However, the dosage forms of the invention are also especially useful in the treatment or prevention of diseases Q / ZLQn / ZZnZ / 3 / YILI interstitial pulmonary diseases as defined herein, including sarcoidosis or fibrosis, more specifically pulmonary fibrosis and particularly IPF, as well as conditions that may trigger ILDs, such as systemic sclerosis, rheumatoid arthritis, myositis or systemic lupus erythematosus, or are otherwise associated with ILDs, such as pulmonary hypertension and / or pulmonary arterial hypertension. Those skilled in the art will understand that the term ILD includes any pulmonary condition characterized by an abnormal healing response, including chronic inflammation, scarring, and / or reduced lung function, regardless of the cause, such as sarcoidosis and pulmonary fibrosis (PF), especially intermittent pulmonary fibrosis (IPF). The term may also include diseases and / or conditions known to lead to and / or cause such pulmonary conditions, such as systemic sclerosis. In this regard, a dosage form of the invention is further provided for use in the condition that causes and / or is the cause of an ILD, such as PF or IPF, including systemic sclerosis. In the treatment of pulmonary fibrosis (PF), including pulmonary fibrosis (PF), the dosage forms of the invention may have an antifibrotic effect, reducing fibrosis and preventing further deposition of extracellular matrix. The dosage forms of the invention may affect pulmonary healing / wound healing and also have an anti-apoptotic effect, thereby preventing apoptosis of alveolar endothelial cells, which is an initiating factor in the development of PF. The dosage forms of the invention may also have an antiproliferative effect, thereby reducing the cancer-like proliferation of fibroblasts and myofibroblasts in PF. The dosage forms of the invention may also improve vascular remodeling in PF, thereby reducing secondary pulmonary hypertension. Finally, the dosage forms of the invention may demonstrate anti-inflammatory and anticytokine effects. According to another aspect of the present invention, a method is provided for treating any of the aforementioned conditions, including respiratory viral damage and, more particularly, interstitial lung disease, including pulmonary fibrosis, and in particular interstitial lung disease (ILD). This method comprises administering a therapeutically effective amount of a dosage form of the invention to a person suffering from or susceptible to Q / ZLQn / ZZnZ / 3 / ΥΙΛΙ suffer from said condition. According to another aspect of the present invention, a method for treating tissue damage induced by respiratory viruses in a subject is provided, said method comprising administering a therapeutically effective amount of a dosage form of the invention to a subject in need of said treatment, in particular in which: • the damaged tissue is lung tissue, including respiratory epithelium; • where the damage includes injury and / or dysfunction of the mucous tissue of the respiratory tract caused by a respiratory virus; • Treatment includes the treatment, and / or halting the progression, of a disease that is or has been caused by the virus; • the respiratory virus is a coronavirus, such as SARS-CoV-2, and the disease is SARS, such as COVID-19; or the respiratory virus is an influenza virus, and the disease is the flu; • Treatment includes the treatment of the symptoms of the disease that is, or has been, caused by the virus in question; • Symptoms of injury or disease include one or more of cough, dyspnea, shortness of breath (which may be manifested by the need for supplemental oxygen and / or mechanical ventilation), respiratory failure, pneumonia, fibrosis in one or more internal organs, including the lungs, heart and / or kidneys; and / or • Treatment includes the prevention of respiratory virus-induced morbidity and / or mortality in one or more of the above conditions. The dosage forms of the invention are indicated both in the therapeutic, palliative and / or diagnostic treatment (for example, during the diagnostic study if a condition is suspected), as well as in the prophylactic treatment (by which we include preventing and / or abrogating the deterioration and / or worsening of a condition) of any of the above conditions. Patients include birds and mammals (especially humans). Human patients include both adult and pediatric patients. The latter include patients up to approximately 24 months of age, and patients between approximately 2 and 10 years of age. Q / ZLQn / ZZnZ / 3 / YILI approximately 12 years of age and patients between approximately 12 and approximately 16 years of age. Patients older than approximately 16 years of age may be considered adults for the purposes of the present invention. These different patient populations may receive different doses of C21 or a salt thereof. In the treatment of certain conditions such as respiratory virus-induced tissue damage, it is preferred that C21 or a pharmaceutically acceptable salt thereof be administered to adult patients, more particularly to subjects over 20 years of age, such as over 30 years, including over 40 years, more preferably over 50 years, especially over 60 years, particularly over 70 years, and more particularly over 80 years; and / or to patients (whether or not they are in one of the age groups specified above) with one or more of the following underlying medical conditions: • Chronic (long-term) respiratory diseases, such as pulmonary fibrosis, pulmonary hypertension, pulmonary arterial hypertension, other ILDs, asthma, chronic obstructive pulmonary disease (COPD), emphysema, or bronchitis • Chronic cardiovascular (e.g., heart) disease, such as heart failure, atrial fibrillation, or hypertension • Chronic kidney disease • Chronic liver disease, such as hepatitis • Chronic neurological conditions, such as Parkinson's disease, motor neurone disease, multiple sclerosis, a learning disability, or cerebral palsy • Diabetes • Problems with a patient's spleen, for example, sickle cell disease or if the spleen has been removed • A weakened immune system as a result of conditions, such as HIV and AIDS, or medications such as steroid tablets or chemotherapy • Obesity (e.g., a body mass index (BMI) of 40 or more) • Pregnancy. In this respect, in accordance with several additional aspects of the invention, a method for treating and / or preventing one or more of the Q / ZLQn / ZZnZ / 3 / YILI following conditions: • post-acute sequelae of, for example, SARS-CoV-2 infection (PASC), such as what is known as long COVID, chronic COVID syndrome (CCS) and / or long-running COVID; • acute kidney injury and / or chronic kidney disease; • respiratory diseases such as pulmonary fibrosis, pulmonary hypertension, pulmonary arterial hypertension, asthma, chronic obstructive pulmonary disease (COPD), emphysema and / or bronchitis; and • cardiovascular diseases such as myocardial infarction, heart failure, atrial fibrillation, hypertension or thrombosis and / or embolization, for example, in the heart, lungs and / or brain, all of which may be induced, directly or indirectly, by respiratory viruses (such as SARS-CoV-2), said method comprising administering C21 or a pharmaceutically acceptable salt thereof to a subject in need of such treatment and / or prevention. In relation to (for example) the acute treatment of tissue damage induced by respiratory viruses, doses of C21 or a salt thereof may be administered between one and four times (for example, between 1 and 3 times) daily for up to three (for example, two) months, such as one month, which includes up to three weeks, for example, up to one week, such as 4 days or 3 days. Such treatment periods may be repeated as appropriate. In the event of the development of one or more of the chronic symptoms identified above in this description, such as fibrosis of the lungs and other internal organs, treatment with C21 or a salt thereof may, in addition to and / or instead of the aforementioned acute dosing regimen, be continuous and / or as necessary / required. Relevant active ingredients that can be used in combination therapy with C21 in the treatment of patients with viral infections include standard treatments applied in various ways for viral infections, including antibody therapies (e.g., LYCoV555 / LY-CoV016 (bamlanivimab and etesevimab), LY-CoV555 (bamlanivimab, Eli Lilly), REGN-COV2 (casirivimab and imdevimab), REGN3048-3051, TZLS-501, SNG001 (Synairgen), eculizumab (Soliris; Alexion Pharmaceuticals), ravulizumab (Ultomiris; Alexion Pharmaceuticals), lenzilumab, leronlimab, Q / ZLQn / ZZnZ / 3 / ΥΙΛΙ tocilizumab (Actemra; Roche), sarilumab (Kevzara; Regeneran Pharma), and Octagam (Octapharma)), medicamentos antivirales (por ejemplo, oseltamivir, remdesivir, favilavir, molnupiravir, simeprevir, daclatasvir, sofosbuvir, ribavirina, umifenovir, lopinavir, ritonavir, lopinavir / ritonavir (Kaletra; AbbVie Deutschland GmbH Co. KG), teicoplanina, baricitinib (Olumiant; Eli Lilly), ruxolitinib (Jakavi; Novartis), tofacitinib (Xeljanz; Pfizer), and TMPRSS2 inhibitor, camostat, o mesilato de camostat, Actembra (Roche), TZLS- 501, AT-100 (rhSP-D), MK7110 (CD24Fc; Merck), OYA1 (OyaGen9), BPI-002 (BeyondSpring), NP-120 (Ifenprodil;Algernon Pharmaceuticals), Galidesivir (Biocryst Pharma), anti-inflammatory agents (e.g., NSAIDs such as ibuprofen, ketorolac, naproxen, and the like), chloroquine, hydroxychloroquine, interferons (e.g., interferon beta (interferon beta-1a), tocilizumab (Actemra), lenalidomide, pomalidomide, and thalidomide), analgesics (e.g., paracetamol or opiates), antitussive agents (e.g., dextromethorphan), vaccines (e.g., INO-4800 from Inovio Pharmaceuticals and Beijing Advaccine Biotechnology, if available), COVID-19 convalescent plasma (CCP), and / or passive antibody therapy using blood from individuals who have recovered from SARS-CoV or SARS-CoV-2 infection. Relevant active ingredients that may be used in combination therapy with C21 in the treatment of ILD, such as IPF, include, for example, antifibrotics (e.g., nintedanib and, particularly, pirfenidone); vitamins (e.g., vitamin B, C, and D); mucolytics (e.g., acetylcysteine ​​and ambroxol); corticosteroids, such as cortisone and prednisone; inflammation suppressants, such as cyclophosphamide; other immunosuppressants, such as azathioprine and mycophenolate mofetil; and antioxidants, such as N-acetylcysteine.Relevant active ingredients that may be used in combination therapy with C21 in the treatment of sarcoidosis include, for example, corticosteroids such as cortisone, prednisone and prednisolone; antimetabolites; immune system suppressants such as methotrexate, azathioprine, leflunomide, mycophenic acid / mycophenolate mofetil, cyclophosphamide; aminoquinolines; anti-tumor necrosis factor monoclonal antibodies such as infliximab and adalimumab; immunomodulatory drugs such as lenalidomide, pomalidomide and. Q / ZLQn / ZZnZ / 3 / YILI especially, thalidomide; the TNF inhibitor, etanercept; and analgesics, such as ibuprofen and paracetamol; cough suppressants and / or expectorants. To avoid confusion, corticosteroids, as mentioned above, include both natural and synthetic corticosteroids. Natural corticosteroids that may be mentioned include cortisol (hydrocortisone), aldosterone, corticosterone, cortisone, pregnenolone, progesterone, as well as natural precursors and intermediates in the biosynthesis of corticosteroids and other derivatives of natural corticosteroids, such as 11-deoxycortisol, 21-deoxycortisol, 11-dehydrocorticosterone, 11-deoxycorticosterone, 18-hydroxy-11-deoxycorticosterone, 18-hydroxycorticosterone, 21-deoxycortisone, 11β-hydroxypregnenolone, 11β,17α, 21-trihydroxypregnenolone, 17α, 21-dihydroxypregnenolone, 17α-hydroxypregnenolone, 21-hydroxypregnenolone, 11-ketoprogesterone, 11β-hydroxyprogesterone, 17αhydroxyprogesterone and 18-hydroxyprogesterone. Among the synthetic corticosteroids that can be mentioned are those of the hydrocortisone type (Group A), such as cortisone acetate, hydrocortisone aceponate, hydrocortisone acetate, hydrocortisone buteprate, hydrocortisone butyrate, hydrocortisone valerate, tixocortol and tixocortisone pivalate, prednisolone, methylprednisolone, prednisone, chlorprednisone, cloprednol, difluprednate, fludrocortisone, fluocinolone, fluperolone, fluprednisolone, loteprednol, prednicarbate and triamcinolone;Acetonides and related substances (Group B), such as amcinonide, budesonide, desonide, fluocinolone ketonide, fluocinonide, halcinonide, triamcinolone acetonide, ciclesonide, deflazacort, formocortal, fludroxycortide, flunisolide and fluocinolone acetonide, those of the (beta)metasone type (Group C), such as beclomethasone, betamethasone, betamethasone dipropionate and betamethasone valerate, dexamethasone, fluocortolone, halomethasone, mometasone and mometasone furoate, alclomethasone and alclomethasone dipropionate, clobetasol and clobetasol propionate, clobetasone and clobetasone butyrate, clocortolone, desoximethasone, diflorasone, difluocortolone, fluchlorolone, flumethasone, fluocortin, fluprednidene and fluprednidenum acetate, fluticasone, fluticasone furoate and fluticasone propionate, meprednisone, paramethasone, prednilidene, rimexolone and ulobetasol; those of the progesterone type; Q / ZLQn / ZZnZ / 3 / YILI such as flugestone, fluorometholone, medrisone and prebediolone acetate, and progesterone derivatives (progestins) such as chlormadinone acetate, cyproterone acetate, medrogestone, medroxyprogesterone acetate, megestrol acetate and segesterone acetate; as well as other corticosteroids such as cortivazol and 6-methyl-11β,17βdihydroxy-17a-(1-propynyl)androsta-1,4,6-trien-3-one. Preferred corticosteroids include cortisone, prednisone, prednisolone, methylprednisolone, and especially dexamethasone. In addition, relevant active ingredients that can be used in combination therapy with C21 (e.g., to treat respiratory viral infections) include H2 receptor blockers, anticoagulants, antiplatelet drugs, as well as statins, antimicrobial agents, and anti-allergy / anti-asthmatic drugs. H2 receptor blockers that may be mentioned include famotidine. Anticoagulants that may be mentioned include heparin and low molecular weight heparins (e.g., bemiparin, nadroparin, reviparin, enoxaparin, parnaparin, certoparin, dalteparin, tinzaparin); direct oral anticoagulants (e.g., dabigatran, argatroban, rivaroxaban, apixaban, edoxaban, betrixaban, darexaban, otamixaban, letaxaban, eribaxaban, hirudin, lepirudin, and bivalirudin); coumarin-type vitamin K antagonists (e.g., coumarin, acenocoumarol, phenprocoumon, atromentin, and phenindione) and synthetic pentasaccharide inhibitors of factor Xa (e.g., fondaparinux, idraparinux, and idrabiotaparinux).Antiplatelet drugs that may be mentioned include irreversible cyclooxygenase inhibitors (e.g., aspirin and triflusal); adenosine diphosphate receptor inhibitors (e.g., cangrelor, clopidogrel, prasugrel, ticagrelor, and ticlopidine); phosphodiesterase inhibitors (e.g., cilostazol); protease-activated receptor 1 antagonists (e.g., vorapaxar); glycoprotein IIB / IIIA inhibitors (e.g., abciximab, eptifibatide, and tirofiban); adenosine reuptake inhibitors (e.g., dipyridamole); and thromboxane inhibitors (e.g., terutroban, ramatroban, seratrodast, and picotamide). Statins that may be mentioned include atorvastatin, simvastatin, and rosuvastatin. Antimicrobial agents that may be mentioned include azithromycin and ceftriaxone. Q / ZLQn / ZZnZ / 3 / YILI cefuroxime, doxycycline, fluconazole, piperacillin, tazobactam, and teicoplanin. Antiallergic / antiasthmatic drugs that may be mentioned include chlorphenamine, levocetirizine, and montelukast. Other relevant active ingredients that may be used in combination therapy with C21 (e.g., to treat respiratory viral infections) include other AT2 agonists known in the art, as well as in combination with AT1 receptor antagonists known in the art, and / or in combination with an angiotensin-converting enzyme (ACE) inhibitor. Non-exhaustive but illustrative examples of AT1 receptor antagonists that may be used according to the modalities include azilsartan, candesartan, eprosartan, fimasartan, irbesartan, losartan, milfasartan, olmesartan, pomisartan, pratosartan, ripiasartan, saprisartan, tasosartan, telmisartan, valsartan, and / or combinations thereof.Non-limiting but illustrative examples of ACE inhibitors that may be used according to the modalities include capipril, zofenopril, enalapril, ramipril, quinapril, perindopril, lisinopril, benazepril, imidapril, irondolapril, fosinopril, moexipril, cilazapril, spirapril, ilemocapril, alacepril, ceronapril, delepril, movelipril and / or combinations thereof. Relevant patients may also receive (and / or may already be receiving) one or more of the treatments and / or other therapeutic agents mentioned above for the relevant condition depending on the administration of one or more of such active ingredients, meaning receiving a prescribed dose of one or more of the active ingredients mentioned herein, before, in addition to and / or after C21 treatment or a salt thereof. The pharmaceutically acceptable salts and dosages of other active ingredients mentioned above include those known in the art and described for the drugs in question in the medical literature, such as Martindale - The Complete Drug Reference, 38th edition, Pharmaceutical Press, London (2014) and the documents referenced herein; relevant descriptions of which are incorporated herein by reference. The dosage forms of the invention have the advantage that they can be manufactured and stored under normal storage conditions, even without freezing and / or exposure to light, while maintaining stability. Q / ZLQn / ZZnZ / 3 / YILI pharmaceutically acceptable physicochemical properties of the composition contained with the capsule and, in particular, the active ingredient. The dosage forms of the invention can also provide an enhanced drug load, allowing for the delivery of high amounts / doses of the active compound and the efficient administration of such higher doses in a consistent / uniform manner. This, in turn, improves the efficacy and efficiency of the treatment and reduces healthcare costs. The uses / methods described herein may have the advantage that, in the treatment of one or more of the conditions mentioned above, and in particular interstitial lung diseases and / or respiratory viral infections, they may be more convenient for the physician and / or patient, be more effective, be less toxic, have a wider range of activity, be more potent, produce fewer side effects than similar methods (treatments), or have other useful pharmacological properties compared to these, which are known in the prior art, whether used in these conditions or others. Whenever the expression "approximately" is used herein, for example, in the context of numbers or quantities, i.e., absolute quantities such as sizes (e.g., particle sizes), dosages, weights or concentrations of ingredients (e.g., active ingredients), ages, temperatures, or time periods; or relative quantities, including percentages and standard deviations, it shall be understood that such variables are approximate and, as such, may vary by ±10%, e.g., ±5%, and preferably ±2% (e.g., ±1%) from the actual numbers specified. In this sense, the term "approximately 10%" means, e.g., ±10% approximately the number 10, i.e., between 9% and 11%. The invention is illustrated, but not limited in any way, by the following examples, in which Figure 1 shows the instability of the sodium salt C21 in the presence of numerous standard excipients. Examples Comparative Example 1 Solubility of C21 in water The solubility of free C21 in several different aqueous vehicles was investigated, as summarized in Table 1 below. The vehicles (with their sources) were as follows: sodium chloride (Sigma), ethanol (99.5%, Kemetyl), polyethylene glycols (BASF), phosphate-buffered saline (PBS) pH 7.4 (Sigma), pH 2.00 buffer solution (citric acid, sodium hydroxide, hydrogen chloride), pH 4.00 buffer solution (citric acid, sodium hydroxide), pH 6.00 buffer solution (citric acid, sodium hydroxide), pH 8.00 buffer solution (boric acid, sodium hydroxide, hydrogen chloride) and pH 10.00 buffer solution (boric acid, sodium hydroxide, hydrogen chloride) (all from Merck), and purified water (Elga Option 4 water purifier). Saturated solutions of free C21 (obtained from Syntagon AB, Sódertálje, Sweden) were prepared in duplicate. Samples were kept under magnetic stirring for 48 hours before analysis. For some samples, the added substance was dissolved and then more was added to obtain saturated solutions. After 48 hours, the pH was measured and then 1 mL of solution was extracted. The undissolved substance was removed by centrifugation (1500 rpm, 30 minutes). The supernatant was diluted 10 to 500 times with acetonityl / H2O, 30:70. The C21 content was measured by HPLC. Q / ZLQn / ZZnZ / 3 / YILI Table 1 Vehicle Concentration (mg / mL)a pH H2O 0.9% NaCl 0.15 0.12 7.3 7.3 0.9% NaCl 1.58b 8.3c 0.9% NaCl 27.40 9.7c 0.9% NaCl / EtOH 95:5 v / v 0.57b 7.9 Buffer / Citric Acid pH 2.0 Buffer / Citric Acid pH 4.0 3.95 6708 2.3 4.0 Buffer / Citric Acid pH 6.0 0.06 6.0 Buffer / PBS pH 7.4 Buffer / Boric Acid pH 8.0 0.24 0.50 7.7 7.9 Buffer / Boric Acid pH 10.0 19.10, 19.90 8.7 PEG / H2O (25:75) 0.17 5.5 PG / H2O (10:90) PG / H2O (25:75) 0.22 0.30 7.5 6.9 PEG / EtOH / H2O (40:10:50) 0.83 6.1 PG / EtOH / H2O (40:10:50) 0.79 6.3 Q / ZLQn / ZZnZ / 3 / YILIaConcentrations are average values ​​of two separate samplesbConcentrations are average values ​​of two injections (one sample)cpH was adjusted by the addition of NaOH Above a pH of approximately 8.5, there is a marked increase in the solubility of free C21. Solubilities up to 27.4 mg / mL are obtained at pH 9.7 in a 0.9% NaCl solution. Increased solubility was also observed in the co-solvent systems studied. However, the change was not as dramatic as that caused by pH modification. The solubility of sodium salt O21 was measured by a similar experiment and was found to be considerably higher than that of free C21. In this experiment, sodium salt 021 (Syntagon AB) was added to the vehicle in small amounts at a time. Approximately 20–30 mg of the sodium salt dissolved readily in all vehicles tested. Salt was added continuously to the same sample in an attempt to obtain a saturated solution. In this way, larger amounts, such as 40– 60 mg / mL. The solubility is probably even higher than this in the tested vehicles, but this was not established due to the limited amount of drug compound available. The results are summarized in Table 2 below. Q / ZLQn / ZZnZ / 3 / YILI Table 2 Vehicle Concentration (mg / mL) at pH H2O >65 9.8 0.9% NaCl >40 9.3 PBS pH 7.4 >40 9.4 Q / ZLQn / ZZnZ / 3 / YILIa Concentrations are average values ​​of two separate samples Comparative Example 2 Sensitivity of aqueous solutions of C21 to light The stability of free C21 in 0.9% NaCI pH 9.4 was investigated. Solutions of 1 mg / mL C21 were studied for four weeks under four different storage conditions. The solution was filtered through a sterile 0.22 syringe filter to minimize bacterial growth during the stability test. Samples were analyzed by HPLC for purity. The results are summarized in Table 3 below, which shows the amount of C21 as a percentage of the initial amount of drug. The pH of the solution was also measured and is shown in parentheses in Table 3. Table 3 Storage time (weeks) Amount of free C21, % of initial 5 °C, darkness RT, darkness RT, light 40 °C, darkness Initial3 100 (9.4) 100 (9.4) 100(9.4) 100 (9.4) 1a 101 (9.2) 97 (9.2) 96(9.0) 101 (9.0) 2b 107 (9.2) 109 (8.9) 44(8.0) 111 (8.6) 3b 108 (9.1) 105 (9.0) 96(8.5) 106 (8.7) 4b 108 (9.2) 106 (8.9) 13(7.7) 107 (8.7) Analyst A Analyst B Free C21 was found to be chemically stable when stored in the dark at 5°C, room temperature (RT), and 40°C for four weeks. There appears to be a slight decrease in pH when the solution is stored at room temperature or higher, but not when stored under refrigeration. The peaks in the HPLC chromatogram corresponding to impurities / degradation products were followed by their respective peak areas. The total impurity peak area was approximately 2.5% of the C21 peak area for samples stored at 5 °C, room temperature / darkness, and 40 °C.There is a clear increase in the number of impurity peaks in the samples stored at room temperature / in light, suggesting that the substance chemically degrades when exposed to light (at least in the presence of water). Specifically, under these storage conditions, a peak with a relative retention time of 0.84, corresponding to 6.9 minutes, appears. Precipitation was observed in the samples stored for two and four weeks at room temperature / in light; therefore, the samples were filtered (0.45 µm, GHP / Acrodisc) before analysis. The comparatively low content of 44% and 13%, respectively, may be due to the precipitation of C21, which can occur at pH below 8.0. However, it is clear that the decrease in content is also due to the formation of degradation products under these storage conditions.Other impurity peaks were observed by HPLC, which are probably related to the degradation of C21 under this storage condition. One possible explanation for the drop in pH in the sample stored for several weeks in RT / light is that the degradation of the substance causes a decrease in pH which, in turn, sets a limit for the solubility of C21 itself. The stability of sodium salt C21 was also investigated under the same storage conditions. The results are summarized in Table 4 below. Q / ZLQn / ZZnZ / 3 / YILI Table 4 Storage time (weeks) Amount of free C21, % of initial 5 °C, darkness RT, darkness RT, light 40 °C, darkness Initial3 100 (8.3) 100 (8.3) 100 (8-3) 100 (8.3) 1a 108 (8-5) 115 (8.6) 108 (8-4) 111 (8-6) 2b 113 (8.4) 110 (8.8) 96 (8.0) 111 (8-5) 3b 113 (8.5) 111 (8.8) 72 (8.3) 109 (8-7) 4b 112 (8.5) 112 (8.2) 9 (7.3) 118 (8-1) Analyst A Analyst B During the analysis of the one-week sample collection, it was observed that the heating cabinet for storing samples at 40 °C was broken. Therefore, these samples were subsequently kept at room temperature for three days. As with free C21, the sodium salt is chemically stable after 4 weeks when kept in the dark at all temperatures studied. For samples stored at room temperature / light, a peak occurs at the same relative retention time observed for free C21. There are also several other peaks, which were thought to be related to light-induced degradation. Therefore, the conclusion is that light-induced degradation occurs in both the sodium salt and free C21. This presented a significant challenge for the development of C21. For any future pharmaceutical product, it is difficult to guarantee that ambient (or higher) temperatures, light, and humidity are completely avoided simultaneously during drug manufacturing, formulation manufacturing, packaging, transportation, and storage. Subsequently, C21 was formulated as the sodium salt in an aqueous solution in the presence of a carbonate buffer for oral dosage, at concentrations of 0.2 and 10 mg / mL for further preclinical and clinical development. These frozen formulations were found to be chemically stable for 3 months when stored refrigerated in polyethylene terephthalate (PET) bottles and for 36 months when stored in a freezer at -15 °C, with no observed changes in pH, appearance, or assay. Comparative Example 3 Attempts to make dry mixes Turbula manufactured two single-mix capsule formulations comprising C21 sodium salt (obtained from Syntagon AB, Sódertálje, Sweden) Q / ZLQn / ZZnZ / 3 / YILI was mixed for 20 minutes at 67 rpm. Ten capsules were filled with each of the simple mixtures having the compositions presented in Table 5 below. The capsules from each batch were divided into three groups; stored in a freezer, at room temperature, and at 40 °C for 6 weeks. Q / ZLQn / ZZnZ / 3 / YILI Table 5 Ingredient Amount / Capsule (nominal in mg) Batch 1 Batch 2 C21 as sodium salt 25 25 D-Mannitol 264 - Sodium starch glycolate 31 - MCC, Pharmacel 102 - 226 Croscarmellose sodium - 16 Hard gelatin capsule 96 96 Nominal weight / Capsule 388 363 (Sources: D-mannitol (Sigma Aldrich); sodium starch glycolate (Glycolys®; Roquette); microcrystalline cellulose (MCC, Pharmacel® 102, DFE Pharma); croscarmellose sodium (Vivasol®; JRS Pharma) and hard gelatin capsule (Licaps® Gel TO Orange, Capsugel).) Three capsules from each batch and storage condition were analyzed after 6 weeks. The test results, homogeneity, and the 15 related impurities are presented in Tables 6 (Batch 1) and 7 (Batch 2) below. Table 6 Storage condition Capsule no. C21 original found from label indication (%) Impurities (Area-%) 1 2 Sum (> 0.05) Freezer / 6 weeks 1 97 0.23 0.02 0.23 2 98 0.23 0.02 0.23 3 106 0.25 0.02 0.25 Average 100 0.24 0.02 0.24 % RSD 4.9 RT / 6 weeks 1 95 0.25 0.04 0.25 2 3 Average % RSD 106 92 98 7.5 0.25 0.24 0.25 0.04 0.04 0.04 0.25 0.24 0.25 40 °C / 6 weeks 1 94 0.34 0.15 0.49 2 91 0.33 0.16 0.48 3 101 0.32 0.14 0.47 Average % RSD 95 5.4 0.33 0.15 0.48 Q / ZLQn / ZZnZ / 3 / YILI Table 7 Storage Condition Capsule No. C21 Original Found From Label Indication (%) Impurities (Area-%) 1 2 Sum (> 0.05) Freezer / 6 weeks 1 105 0.25 0.03 0.25 2 112 0.25 0.02 0.25 3 97 0.25 0.03 0.25 Average % RSD 105 7.0 0.25 0.03 0.25 RT / 6 weeks 1 90 0.28 0.02 0.28 2 95 0.28 0.03 0.28 3 97 N / A* N / A* N / A* Average % RSD 94 3.8 0.28 0.03 0.28 40 °C / 6 weeks 1 96 0.53 0.03 0.53 2 91 0.54 0.03 0.54 3 90 0.55 0.03 0.55 average % RSD 92 3.6 0.54 0.03 0.54 *) Excluded for impurity determinations since the syringe filter Q / ZLQn / ZZnZ / 3 / YILI specific used for this sample provides adsorption of Impurity 1 (formerly known for C21). For each batch, the average assay under freezer storage conditions was found to be close to 100%. For both batches, the assay decreased in the following order: freezer, RT, 40 °C. In addition, the total sum of organic impurities increased by the same order for both batches. Significant variability was observed in the test results within each set of capsules. In Lot 1, the total impurity was 0.24% area units higher for storage at 40°C compared to freezing. The novel Impurity 2 accounted for the largest increase, from 0.02% to 0.15% area. The known Impurity 1 increased by 0.09% area units. Two additional impurity peaks also formed just below the reporting limit of 0.05% area. In Lot 2, the total sum of impurities was 0.29 units of % area greater for storage at 40 °C compared to the freezer. This increase is solely due to an increase in Impurity 1. Three capsules from each batch, stored at room temperature, were analyzed for dissolution. Batch 1 was completely released within 15 minutes, with low variability in the data. For Batch 2, two of the three capsules were completely released within 30 minutes, but there was high variability in the results. The degradation of C21 in the first two single-mix capsule formulations observed during stability testing was considered unacceptably high. The chemical stability of the C21 capsule formulation became the primary focus of ongoing development work. Furthermore, it was concluded that further work might be necessary to achieve a homogeneous powder mixture. Comparative Example 4 Compatibility study The excipients used in the capsules of Comparative Example 3 above were evaluated together with some additional ones (see Table 8 below). The C21 (sodium salt) used in these experiments was ground and passed through a 300 pm sieve. Mixtures of each excipient and C21 were prepared by thoroughly mixing them in the amounts specified in Table 8. The ratio of C21 to various fillers (D-mannitol, MCC, lactose monohydrate, and HPMC) was adjusted to give a volume equivalent to most of a capsule. Three capsules of each type were filled with C21. All preparations were stored under accelerated stability conditions at 60 °C for 12 days prior to analysis. Table 8 Q / ZLQn / ZZnZ / 3 / YILI Chemical Sample Number 1 2 3 4 5 6 7 8 9 10 C21 (mg) 26 26 25 25 24 26 25 25 25 25 D-Mannitol (mg) 464 - - - - - - - - - Starch Glycolate - 35 - - - - - - - - Sodium (mg) MCC, Pharmacel 102 (mg) - - 229 - - - - - - - Croscarmellose sodium (mg) - - - 17 - - - - - - Hard gelatin capsule - - - - 3 pcs - - - - - MCC, Vivapur 102 (mg) - - - - - 229 - - - - Lactose monohydrate (mg) - - - - - - 249 - - - HPMC Methocel (mg) - - - - - - - 259 - - HPMC capsule - - - - - - - - 3 pcs - (Sources of materials other than those analyzed above: MCC (Vivapur® 102, JRS Pharma); lactose monohydrate (InhaLac® 400, Meggle); hydroxypropylmethylcellulose (HPMC, Methocel™ K100 Premium, Colorcon); and HPMC capsules (Licaps® size 0; Capsugel).) The results of the related impurity analysis after 12 days at 60 °C are presented in Table 9 below and in Figure 1. Table 9 Deaeration Sample No. Chemical Sum of Impurities (>0.05%) Individual Impurity (% of area) 1 2 3 4 5 1 D-Mannitol 0.26 0.26 2 Sodium Starch Glycolate 0.73 0.53 0.20 3 MCC Pharmacel 102 11.1 11.0 0.0 4 Croscarmellose Sodium 0.52 0.52 5 Licaps Hard Gelatin Capsule 0.28 0.28 6 MCC Vivapur 102 0.56 0.56 7 Lactose Monohydrate 0.48 0.40 0.08 8 HPMC Methocel 1.74 1.74 9 HPMC Licaps capsule 0.35 0.30 0.05 10 REF Solo C21 0.26 0.26 Q / ZLQn / ZZnZ / 3 / YILI No degradation of C21 was observed in Samples 1 and 5 in the accelerated stability study, nor in the reference sample. Extensive degradation of C21 to Impurity 1 occurred in Sample 3, and similar degradation occurred in Sample 8. All other mixtures showed degradation of C21, and in some mixtures, new degradation products formed in addition to the known Impurity 1. In addition to the disintegrants (sodium starch glycolate and croscarmellose sodium) mentioned above, crospovidone of two different types (Kollidon® CL (Type A) and Kollidon® CL-SF (Type B) (both BASF)) was tested. Mixtures of 130 mg of crospovidone and 200 mg of C21 were prepared and thoroughly mixed using a Turbula mixer for 10 minutes. All preparations were analyzed at baseline and after storage under accelerated stability conditions at 60 °C for 12 days. The results of the related impurity analyses for the study conducted at 60 °C are presented in Table 10 below. No significant C21 degradation was observed in any of the mixtures. Impurity peaks 6 and 7, observed using Kollidon CL, were present at baseline. Table 10 Kollidon tested Time point (days) Sum of impurity s(> 0.05 %) Individual impurity (% of area) 1 6 7 CL, type A 0 0.26 0.26 0.01 0.01 12 0.28 0.28 0.01 0.01 CL-SF, type B 0 0.25 0.25 nd1 nd1 12 0.25 0.25 nd1 nd1 1The peak is <0.003% of area The compatibility test shows that C21 is stable together with mannitol, both types of Kollidon, CL and CL-SF, and Licaps hard gelatin capsules, but that there are several stability problems with all other excipients tested. Comparative Example 5 Mixture studies The ability to produce homogeneous powdered mixtures of C21 sodium salt was a major concern after the first experiments in formulating simple mixture capsules (see Comparative Example 3 above). Mannitols of different grades than those mentioned in Comparative Examples 3 and 4 above were selected for further study with a view to determining appropriate mixing parameters and providing a chemically stable and homogeneous powder mixture that could be filled into capsules. Sodium salt C21 was used along with 7 different types of mannitol from two different manufacturers. C21 and mannitol were added to glass flasks and mixed using a Turbula mixer. After a mixing time of 30 minutes, homogeneity samples were taken from each flask and the associated impurities were analyzed. An aliquot of each powder mixture was also subjected to 60 °C for 12 days in a stability analysis. The nominal C21 content was 7.4% w / w (calculated as free C21) for all mannitol mixtures except one, in which an additional concentration of 14.8% w / w was also tested. The results are presented in Table 11 below. Q / ZLQn / ZZnZ / 3 / YILI Table 11 Mannitol Sample Preparation C21 found from label indication (%) Manogem EZ spray dried 1 2 3 Average value % RSD 98.9 101.8 99.2 99.9 1.6 Manogem EZ spray dried (with C21 14.8 % w / w) 1 2 3 Average value % RSD 95.3 104.1 89.3 96.2 7.7 Mannogem Granular 1 2 3 Average value % RSD 66.5 71.7 67.6 68.6 4.0 Mannogem 2080 Granular 1 2 3 Average value % RSD 78.5 108.3 93.6 93.5 16 Pearlitol 100 SD 1 2 3 Average value % RSD 99.7 88.7 153.2 114 30 Pearlitol 200 SD 1 2 3 Average value % RSD 101.3 132.6 126.0 120 14 Pearlitol 300 DC 1 2 3 Average value % RSD 59.6 73.9 75.9 70 13 Pearlitol 500 DC 1 2 3 Average value % RSD 70.2 66.5 64.0 67 4.6 (Sources: all types of Mannogem® (SPI Pharma) and all types of Pearlitol® (Roquette).) Q / ZLQn / ZZnZ / 3 / YILI Only acceptable homogeneity was observed for both concentrations of spray-dried mannitol Mannogem EZ (average particle diameter of 150 to 200 pm). However, variability was observed in the data points, which, while reasonable for the 7.4% concentration, was much greater for the 14.8% concentration. All other mannitol types showed insufficient homogeneity and high or very high variability. In this regard, it was observed that in the flasks where Mannogem Granular, Pearlitol 300 DC, and Pearlitol 500 DC were mixed, some of the material adhered strongly to the glass walls. Based on the low amount of C21 found, it is believed that a higher amount of API was present in this sticky material. The results of the accelerated stability study conducted at 60 °C for 12 days are presented in Table 12 below. Q / ZLQn / ZZnZ / 3 / YILI Table 12 Material and type Impurities >0.05 % formed (% of area) 1 2 3 8 9 C21 only, reference value 0.26 - - - - Manitol Mannogem EZ dried by powder reference - - - - - Manitol Mannogem EZ dried by powder 0.26 - - 0.01 0.01 Manitol Mannogem EZ dried by powder 14.8 % C21 0.26 0.01 0.02 0.01 0.01 Manitol Mannogem Granular 0.27 0.01 0.02 0.01 0.01 Manitol Mannogem 2080 Granular 0.27 - - 0.01 0.01 Manitol Pearlitol 100 SD 0.29 0.01 0.02 0.04 0.04 Manitol Pearlitol 200 SD 0.26 ** ** 0.01 0.02 Manitol Pearlitol 300 DC 0.28 - 0.02 0.03 0.04 Manitol Pearlitol 500 DC 0.29 0.02 0.06 0.03 0.04 Crospovidona Kollidon CL 0.28 0.01* 0.01* - - Crospovidona Kollidon CL-SF 0.25 - - - - Q / ZLQn / ZZnZ / 3 / ΥΙΛΙ C21 was found to be fairly stable against all types of mannitol, although two new impurities formed against all five types tested (numbered 8 and 9 above). An accelerated stability study of 8 days at 60 °C demonstrated that these two impurities were not mannitol degradation products. In any case, the levels of these impurities were low. Two other impurities were previously detected in the Kollidon mixture experiments (see Comparative Example 4 above). These impurities were suspected to be non-homogeneously distributed C21 degradation products. The impurities seemed to come and go, which is not easily explained. The known Impurity 1 showed a smaller increase. Comparative example 6 Expanded mixing studies C21 and spray-dried Mannogem EZ mannitol were added to glass flasks and mixed in a Turbula mixer. The nominal C21 content was 7.78% w / w (calculated as free C21). After mixing times of 15, 30, 45, 60, and 90 minutes, five samples were taken from the flask for homogeneity analysis. After the last sample was taken at 90 minutes, the remaining batch was passed through a 300 µm sieve, placed in a glass flask, and then further mixed in a Turbula mixer for 30 minutes before sampling. The results are presented in Table 13 below. Q / ZLQn / ZZnZ / 3 / YILI Table 13 Mixing Time (min) Sample Preparation C21 found from label indication (%) 15 1 103.3 2 89.7 3 95.3 4 91.9 5 100.8 Average value 96.2 % RSD 6.0 30 1 99.5 2 102.4 3 99.5 4 97.4 5 109.7 Average value 101.7 % RSD 4.7 45 1 102.9 2 105.6 3 102.9 4 105.3 5 96.3 Average value 102.6 % RSD 3.7 60 1 103.1 2 108.8 3 94.2 4 110.9 5 100.0 Average value 103.4 OL Den RR 90 1 96.6 2 104.8 3 103.1 4 103.1 5 100.4 Average value 101.6 % RSD 3.1 90 + sieving and 1 87.7 mixture 2 89.2 3 89.1 4 88.7 5 88.7 Q / ZLQn / ZZnZ / 3 / YILI Average value % RSD 88.7 0.67 Q / ZLQn / ZZnZ / 3 / YILI The mean value for the C21 test is close to 100% when using a mixing time of 30 minutes or more compared to a mixing time of 15 minutes. However, there is a high degree of variability (3–7% RSD) in the test at each mixing time up to 90 minutes. Furthermore, paradoxically, homogeneity did not improve with mixing time. The good homogeneity found for spray-dried Mannogem EZ during the sieving of different types of mannitol (see Comparative Example 5 above) could not be replicated. The final sieving and mixing yielded a homogeneous mixture with an RSD of 0.7%, but the C21 assay decreased substantially from 102% to 89%. This decrease is most likely due to the C21 particle size distribution containing more aggregates in the 100–400 µm range. Comparative Example 7 Mixture after micronization The decision was then made to attempt to micronize C21 before continuing the mannitol mixing experiments. An aliquot of C21 was sent to Jetpharma (Balerna, Switzerland) for micronization by jet milling in order to break up the aggregates to a particle size of 100 to 400 pm in order to make a homogeneous mixture with mannitol. The chemical purity of C21 was found not to change significantly during micronization, and the particle size distribution of the crystals in the material became narrower. Optical microscopy of jet-ground C21 showed that the crystals were rod-shaped with lengths from a few pm to 50 pm. The crystals attracted each other, forming loose clusters. Micronized C21 and spray-dried mannitol (Mannogem EZ) were mixed similarly to that described in Comparative Example 6 above. Again, although the mean value for the C21 assay was close to the 100% when a mixing time of 45 minutes or more was used, there was a large variability (4 to 10% RSD) in the test at each mixing time. Furthermore, again, the final sieving and mixing yielded a homogeneous mixture, 0.7% RSD, but the C21 assay decreased substantially from 103% to 88%. This decrease is of the same magnitude as the loss observed in Comparative Example 6 above for non-micronized C21. Comparative Example 8 Mix using a slider During the mixing experiments, it was observed that some of the powder mixture adhered strongly to the walls of the glass flask. Therefore, regardless of how uniform the particle size was before mixing, the results clearly indicated that C21 has a propensity to form aggregates. An attempt was made to solve this problem by adding colloidal silica. Micronized and non-micronized C21 was used (see Comparative Example 7 above) and mixed with mannitol (spray-dried Mannogem EZ) and Aerosil 200 colloidal silica. C21 was premixed with colloidal silica (Aerosil® 200 Pharma, Evonik Industries) in a glass flask for 10 minutes using a Turbula mixer before adding mannitol with continuous mixing. The same mixing and sampling procedure as described above was used. During mixing, lumps were observed, which decreased in number with longer mixing times. The mannitol itself contained lumps from the beginning, which disintegrated easily. After a mixing time of 30 minutes, a single lump with a mass of 36 mg (approximately 1 / 10 of the amount in one capsule) was isolated and analyzed. The C21 content in that lump was only 24% of the nominal content, indicating that it may be necessary to sieve the mannitol before mixing it with C21. In the homogeneity analysis, the mean value for the C21 test is initially very high (205%), but it dropped to around 100% with a mixing time of 30 minutes or more. The variability decreases steadily with Q / ZLQn / ZZnZ / 3 / YILI the increase in mixing time, but at best it is 6% (i.e., far from acceptable). The final sieving and mixing yielded a fairly homogeneous mixture (1.6% RSD), but the C21 assay decreased substantially from 103% to 75%. This decrease was even greater than that observed in Comparative Examples 5 and 6 above (i.e., without colloidal silica), which was quite surprising. Similar results were observed for micronized C21. Again, C21 tended to clump. Homogeneity increased after 30 minutes of mixing and then decreased with longer mixing times. The assay ended unexpectedly low (90%). Although variability steadily decreased with increasing mixing time, it was at best 11% (i.e., far from acceptable). The final sieving and mixing resulted in a fairly homogeneous mixture (1.2% RSD), but the C21 assay had decreased substantially from 90% to 81%. The tendency for the assay to decrease to values ​​below 100% after 60 minutes indicated serious mixing problems. It was found that it was only possible to make something resembling a homogeneous mixture after extensive mixing followed by sieving and final mixing. Comparative example 9 Change of container An attempt was made to determine if the nature of the mixing container had any effect on the outcome. C21 and mannitol (Mannogem EZ atomized) were passed through a 300 µm sieve to remove lumps. The ingredients were then added to a polyethylene (PE-HD) bottle and mixed as before. Again, during mixing, it was observed that some lumps had formed and that the wall and lid were coated with a layer of powder. The mean value for the C21 test was initially 103% and subsequently decreased until the 60-minute time point. The variability was large but decreased with increasing mixing time. The final sieving and mixing yielded a homogeneous mixture (0.9% RSD) but, once again, the C21 assay had decreased substantially (in Q / ZLQn / ZZnZ / 3 / YILI approximately 16%), implying that the plastic flask had a greater tendency to adsorb C21 than the glass. In fact, the walls of the flask, including the lid, were found to be coated with a layer of powder. In summary, the sodium salt C21 was found to exhibit unexpected chemical instability when mixed in its dry state with many conventional excipients. It also contains needle-like particles and is sticky, causing it to clump together, which makes it difficult to mix with conventional excipients to produce a powder blend with acceptable content uniformity. Furthermore, when the equipment was used for automated weighing, with a screw conveyor, the API stuck to the screw and did not detach into the vials. Example 10 Dosage form of the invention I A mixture of excipients was prepared with a composition comprising mannitol (Pearlitol® 25C (average particle size diameter 25 pm; Roquette; 247.75 g) and colloidal silicon dioxide (Aerosil Evonik; 0.25 g). Approximately half of the weighed amount of mannitol was placed in a 3 L V-shell in a V-mixer (Dott. Bonapace, Limbiate, Italy), followed by all of the colloidal silicon dioxide. The remaining mannitol was then added to the V-shell and mixed for 10 minutes at 30 rpm. Next, the excipient mixture was sieved through an 800 pm sieve, before mixing for another 20 minutes at 30 rpm. Following this, a 500 mL graduated cylinder was weighed and 100 mL of the respective excipient mixture was poured into the cylinder. 50 g of sodium salt C21 (synthesized by Ardena (formerly Syntagon AB), Södertálje, Sweden) was weighed and transferred to the measuring cylinder. The apparent volume (Vbulk) was read. More excipient mixture was then added to bring the volume to 370 mL (in the cylinder). The resulting mixture was gently tapped 10 times, and more excipient mixture was added to bring the volume to 350 mL to compensate for the decrease, followed by 5 more gentle taps (the final volume was 340 mL). The total mass of the filled cylinder was weighed, and the bulk density (dbulk) of the mixture was determined. Q / ZLQn / ZZnZ / 3 / ΥΙΛΙ as 0.4 g / mL. The contents of the measuring cylinder were then transferred to a 3 L V-shaped housing of a V-mixer, mixed for 10 minutes at 30 rpm, then sieved through a 500 pm sieve and finally mixed for 40 minutes at 30 rpm. It was observed that the mixture adhered to the metal walls of the V-shaped housing and that lumps formed. Therefore, it was decided to perform an additional sieving stage through an 800 µm sieve and then mix for a further 30 minutes at 30 rpm. After preparing the mixture, its uniformity was determined by weighing approximately 270 mg of the mixture sample (corresponding to the fill weight of 1 capsule) into a 100 mL volumetric flask, adding 40 mL of MilliQ water and sonicating for 20 minutes, then adding 40 mL of methanol and sonicating for another 20 minutes. After equilibrating at room temperature, 1.0 mL of the sample solution was added to a 10 mL volumetric flask. It was then diluted with methanol and mixed. The sample was filtered through a 0.45 µm PTFE membrane syringe filter, and the first 3 mL of the filtrate were discarded. The amount of sodium C21 salt was determined by UHPLC. The resulting solution should contain 0.1 mg / mL of sodium C21 salt (for 100% of the nominal sample concentration). The results of the mixture uniformity are shown in Table 14 below. Q / ZLQn / ZZnZ / 3 / YILI Table 14 Sample Assay (%, lc) 1 98.0 2 95.4 3 99.9 4 96.7 5 96.2 6 97.6 Mean 97.3 RSD 1.6 Q / ZLQn / ZZnZ / 3 / YILI Good results were observed for mixture uniformity (i.e., mean test values ​​between 95.0 - 105.0%, Le. and RSD below 52.0%). 460 capsules (3 x 120 and 1 x 100; Vcaps® Plus, size 0, opaque white; Capsugel) were filled secundum artem using a Feton® manual encapsulation device. Weight grading was performed applying a tolerance limit of 5% on the net fill weight of one capsule. Content uniformity is determined using the same UHPLC method described above (except that the capsules were weighed, opened, and the contents and cover were transferred to the 100 mL volumetric flask). Thirty capsules were evaluated. The evaluation was performed for n=10 (first 10 to 15 capsules measured) and n=30 capsules. The results for content uniformity are shown in Table 15 below. Table 15 Reproduction Assay (%, lc) Reproduction Assay (%, lc) Reproduction Assay (%, lc) 1 98.5 11 95.3 21 102.5 2 98.5 12 95.0 22 93.4 3 95.8 13 100.7 23 94.4 4 96.5 14 100.5 24 96.0 5 93.6 15 94.9 25 94.3 6 99.7 16 98.3 26 98.8 7 97.0 17 97.1 27 101.3 8 94.4 18 93.2 28 96.4 9 95.0 19 100.0 29 92.7 10 101.0 20 99.1 30 97.6 Mean 97.1 Not applicable SD 2.3 Not applicable n=10 RSD 2.4 Not applicable k 2.4 Not applicable AV 7.0 Not applicable Mean 97.0 SD 2.7 n=30 RSD 2.8 k 2.0 AV 6.9 Q / ZLQn / ZZnZ / 3 / YILI Acceptable content uniformity results were obtained for both n=10 and n=30. Example 11 Dosage form of the invention II A mixture of excipients was prepared essentially as described in Example 10 above, except that the final proportions of mannitol / silica in the final mixture were 99.17:0.83. After its manufacture, 37.725 g of the excipient mixture were weighed and added to the 3 L V-shell of the V-mixer. Next, 50 g of sodium salt C21 were added to the V-shell. Then, another 37.725 g of the excipient mixture were added to the V-shell, and mixed for 10 minutes at 30 rpm. The resulting mixture was then sieved twice through an 800 µm sieve and then mixed for 40 minutes at 30 rpm. This mixture was then sieved through an 800 µm sieve followed by an additional 15 minutes of mixing at 30 rpm. The uniformity of the mixture was then determined essentially according to the procedure described in Example 10 above. After redilution of the initial stock solutions of the sample preparations and reanalysis to exclude laboratory error (dilution), the precise results for the uniformity of the mixture are shown in Table 16 below. Q / ZLQn / ZZnZ / 3 / YILI Table 16 Sample Assay (%, lc) 1 98.0 2 100.4 3 100.3 4 99.8 5 100.1 6 100.7 Mean 99.9 RSD 1.0 Good results in mixture uniformity were observed. The capsules were filled and the uniformity of the contents was determined using the same UHPLC method described in Example 10 above. The results for content uniformity are shown in Tables 17 to 15 below. Table 17 Reproduction Assay (%, lc) Reproduction Assay (%, lc) Reproduction Assay (%, lc) 1 98.0 11 99.4 21 98.1 2 98.3 12 99.0 22 97.9 3 102.5 13 99.5 23 95.1 4 99.5 14 99.7 24 95.9 5 101.4 15 99.5 25 97.8 6 96.9 16 99.0 26 98.4 7 98.4 17 96.0 27 100.8 8 100.3 18 97.4 28 96.9 9 103.2 19 96.4 29 95.5 10 98.4 20 96.0 30 99.0 n = 10 Mean 99.1 Not applicable SD 2.1 Not applicable RSD 2.1 Not applicable k 2.4 Not applicable AV 5.0 Not applicable n = 30 Mean 98.5 SD 2.0 RSD 2.0 k 2.0 AV 3.9 Q / ZLQn / ZZnZ / 3 / YILI Acceptable content uniformity results were obtained for both n=10 and n=30. Example 12 Composition according to invention I A mixture of excipients was prepared by weighing 2.6 g of colloidal silicon dioxide into a weighing vessel. Then, 197.4 g of mannitol (Pearlitol® 50C, mannitol from the same supplier with a slightly larger mean particle diameter (50 µm)) were weighed out, and approximately half of that amount was poured into the 3 L V-shaped housing of the V-mixer. The weighed amount of slide was then added to the V-shaped housing, followed by the remaining mannitol. The resulting mixture was combined for 10 minutes at 30 rpm. Next, the mixture was sieved through an 800 pm sieve and then returned to the mixer to be mixed for 20 minutes at 30 rpm. Approximately 75 mL of the excipient mixture was added to a pre-weighed 500 mL measuring cylinder. 26.4 g of sodium salt C21 was weighed and added to the measuring cylinder, then an additional amount of the excipient mixture was added to bring the total to 370 mL, followed by 10x gentle tapping. More excipient mixture was added to bring the total to 350 mL to compensate for the decrease in volume, followed by 5x gentle tapping (the final verified volume is 340 mL). The total mass of the cylinder with its contents was determined and the net mass of the contents was calculated. Before transferring it to the 3 L V-shaped housing, it was mixed for 10 minutes at 30 rpm, the resulting mixture was sieved through a 400 pm sieve and mixed for another 20 minutes at 30 rpm. Based on the above volume determination, the new composition for 50 mg of C21 / capsule is provided below in Table 18. Q / ZLQn / ZZnZ / 3 / YILI Table 18 Ingredient Composition mg / capsule % w / w Sodium salt C21 52.8 20.44 Mannitol (Pearlitol 50C) 203.38 78.73 Colloidal silicon dioxide (Aerosil 200) 2.14 0.83 Example 13 Composition according to invention II Essentially the same mixing process described in Example 12 above was used to prepare 120 active capsules from 0.642 g of colloidal silicon dioxide, 61.014 g of mannitol (Pearlitol 50C) and 15.84 g of sodium salt C21. After the excipient mixture was made, half was added back into the 3 L V-shell, followed by C21, then the remaining excipient mixture, and then mixed for 10 minutes at 30 rpm, sieved through an 800 pm sieve, and finally mixed again for 20 minutes at 30 rpm. The uniformity of the mixture was determined as described in Example 10 above and the results are shown in Table 19 below. Table 19 Sample Assay (%, lc) 1 99.7 2 98.4 3 97.5 4 101.4 5 98.9 6 98.9 Mean 99.1 RSD 1.4 Q / ZLQn / ZZnZ / 3 / YILI The mixture uniformity results were acceptable. 120 secundum artem capsules were filled using a Feton® manual encapsulation device. Weight classification was performed applying a 5% tolerance limit to the net fill weight of one capsule, and the results were found to be acceptable. Example 14 Dosage form of the invention III (enlarged) 10,000 capsules were prepared using essentially the same mixing process described in Example 13 above, using 21.4 g of colloidal silicon dioxide, 2033.8 g of mannitol (Pearlitol 50C), and 528 g of sodium salt C21 (Ardena, Riga, Latvia). A larger V-blender (Multiblender, Pharmatech, UK) with a 25 L V-shaped housing was used. The uniformity of the mixture was determined as described in Example 10 above and is shown in Table 20 below. Table 20 Sample Assay (%, lc) 1 100.3 2 102.1 3 104.1 4 100.9 5 98.7 6 99.3 Mean 100.9 RSD 1.9 The results for mixture uniformity were acceptable. After this, 26.1 g of magnesium stearate (Ligamed® MF-2-V, Peter Greven, Germany) was sieved through an 800 pm sieve and added to the mixture, followed by a final mixing for 15 minutes at 15 rpm. The final composition is as set out in Table 21 below. Q / ZLQn / ZZnZ / 3 / YILI Table 21 Ingredient Composition mg / capsule % w / w Sodium salt C21 52.8 20.24 mannitol (Pearlitol 50C) 203.38 77.93 colloidal silicon dioxide (Aerosil 200) 2.14 0.82 magnesium stearate (Ligamed MF-2-V) 2.61 1.00 Approximately 6700 capsules were encapsulated using an MG Compact (MG2, Bologna, Italy) with size 0 dispensers, in which the following settings were applied: chamber - 11 mm; compression - 0 mm; powder layer: 30.0 mm. Weight grading was performed applying a 5% tolerance limit to the net fill weight of one capsule, and the result was found to be 18.6%. After encapsulation, the capsules were primarily packaged manually into 100 mL high-density polyethylene (HDPE) bottles with child-resistant and tamper-evident caps containing desiccant (56 capsules / bottle). A total of 97 bottles were produced and labeled for use in a clinical trial. Example 15 Stability study of the pharmaceutical form of the invention The capsules obtained in Example 14 above were tested in a study to evaluate stability in a representative clinical package under ICH (International Council for Harmonisation) storage conditions: (i) 25 °C and 60% RH (long-term storage conditions) and (ii) 40 °C and 75% RH (accelerated storage conditions). The stability data are represented in Table 22 below. Q / ZLQn / ZZnZ / 3 / YILI Table 22 Condition Time (M) Original C21 found vs. label indication (%) Impurity (%, w / w) Solution 1 2 3 Sum Q at 30 min average (min max) Initial 100.8 0.16 0.16 <0.10 0.32 95 (91-98) 25 °C and 60 % RH 1 100.0 0.21 0.16 0.10 0.46 99 (95-102) 3 100.1 0.16 0.17 <0.10 0.33 95 (94-96) 6 99.1 0.22 0.16 <0.10 0.38 104 (102-107) 12 99.7 0.17 0.14 <0.10 0.31 100 (97-103) 40 °C and 75% RH 1 99.6 0.21 0.16 <0.10 0.37 97 (93-104) 3 99.3 0.21 0.18 <0.10 0.38 95 (91-99) 6 100.4 0.25 0.15 <0.10 0.40 101 (96-105) Q / ZLQn / ZZnZ / 3 / YILI No significant changes were observed in the stability results and all results met the applicable acceptance criteria after 12 months of storage at 25 °C and 60% RH and 6 months of storage at 40 °C and 75% RH.

Claims

CLAIMS 1. A pharmaceutical dosage form suitable for oral administration into the gastrointestinal tract, said dosage form comprising a pharmaceutical composition in the form of a particulate mixture comprising: (a) solid particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-isobutylthiophene-2-sulfonamide, or a pharmaceutically acceptable salt thereof, mixed with (b) a mixture of: (i) carrier particles having a weight-based mean diameter and / or a volume-based mean diameter, and / or a structural / particle density, which is / are within approximately ±50% of the respective weight-based mean diameter, volume-based mean diameter, and / or structural / particle density, of the solid particles of N-butyloxycarbonyl-3-(4-imidazol-1-methylphenyl)-5-iso-butylphen-2-sulfonamide or a pharmaceutically acceptable salt thereof, and (ii) a glide,This composition is contained within a capsule that is suitable for oral administration.

2. A dosage form as claimed in Claim 1, wherein the capsule is a two-piece hard-shell capsule.

3. A dosage form as claimed in Claim 2, wherein the capsule is made of hydroxypropyl methylcellulose.

4. A dosage form as claimed in any one of the preceding claims, wherein the particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide or a pharmaceutically acceptable salt thereof have a weight and / or volume-based mean diameter not exceeding approximately 50 µm.

5. A dosing form as claimed in any one of the preceding claims, wherein the carrier particles have a weight- and / or volume-based mean diameter of less than approximately 100 pm.

6. A dosing form as claimed in Claim 5, in Q / ZLQn / ZZnZ / 3 / YILI where the mean diameter is between approximately 20 pm and approximately 60 pm.

7. A dosage form as claimed in any one of the preceding claims, wherein the carrier particle material comprises mannitol.

8. A dosing form as claimed in any one of the preceding claims, wherein the slip comprises a colloidal silica.

9. A dosing form as claimed in any one of the preceding claims, wherein smaller particles of the sliding material coat the carrier particles.

10. A dosing form as claimed in any one of the preceding claims, further comprising a lubricant.

11. A dosage form as claimed in Claim 10, wherein the lubricant is magnesium stearate.

12. A dosage form as claimed in any one of the preceding claims that essentially contains no water.

13. A dosage form as claimed in any one of the preceding claims, wherein the pharmaceutically acceptable salt of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-isobutylthiophene-2-sulfonamide is a sodium salt.

14. A process for producing a dosage form as defined in any one of the preceding claims, said process comprising:

1. mixing the carrier particles and the glide; 2. mixing the mixture of step (a) with particles of N-butyloxycarbonyl-3(4-imidazol-1-ylmethyl-phenyl)-5-iso-butylthiophene-2-sulfonamide or a pharmaceutically acceptable salt thereof; and 3. loading the mixture of step (b) into a capsule suitable for oral administration.

15. A process as claimed in Claim 14, wherein, prior to step (c), a lubricant as defined in Claim 10 or Claim 11 is mixed together with the mixture of step (b).

16. A process as claimed in Claim 14 or Claim 15, wherein the mixture of step (a) and / or step (b) (before and / or after adding the lubricant, as appropriate) is passed through a sieve at least once to break up any agglomeration that forms during the mixing process.

17. A process as claimed in Claim 16, wherein at least one of the sieving steps comprises passing through a sieve having a size of approximately 800 µm.

18. A dosage form that can be obtained by a process as defined in any one of Claims 14 to 17.

19. A dosage form as defined in any one of Claims 1 to 13 or 18 for use in the treatment of an interstitial lung disease.

20. The use of a dosage form as defined in any one of Claims 1 to 13 or 18 for the manufacture of a medicament for the treatment of an interstitial lung disease.

21. A method of treating an interstitial lung disease, said method comprising administering a dosage form as defined in any one of Claims 1 to 13 or 18 to a patient requiring said treatment.

22. A dosage form for use as defined in Claim 19, a use as defined in Claim 20, or a treatment method as defined in Claim 21, wherein the interstitial lung disease is idiopathic pulmonary fibrosis.

23. A dosage form for use as defined in Claim 19, a use as defined in Claim 20, or a method of treatment as defined in Claim 21, wherein the interstitial lung disease is sarcoidosis.

24. A dosage form as defined in any one of Claims 1 to 13 or 18 for use in the treatment of tissue damage induced by respiratory viruses.

25. The use of a dosage form as defined in any one of Claims 1 to 13 or 18 for the manufacture of a medicament for the treatment of tissue damage induced by respiratory viruses.

26. A method for treating tissue damage induced by respiratory viruses, said method comprising administering a dosage form such as Q / ZLQn / ZZnZ / 3 / YILI as defined in any one of Claims 1 to 13 or 18 to a patient requiring said treatment.

27. A dosage form for use as defined in Claim 24, a use as defined in Claim 25, or a treatment method as defined in Claim 26, wherein the injury comprises damage and / or dysfunction of the mucosal tissue of the respiratory tract caused by a respiratory virus.

28. A dosage form for use, a use or a method of treatment as claimed in Claim 27, wherein the respiratory virus is a coronavirus or is an influenza virus.

29. A dosage form for use, a use or a method of treatment as claimed in Claim 28, wherein the respiratory virus is severe acute respiratory syndrome coronavirus 2.

30. A dosage form for use, a use or a method of treatment as claimed in any one of Claims 24 to 29 (as applicable), wherein the treatment includes the treatment of the symptoms of the disease that is, or has been, caused by the virus.

31. A dosage form for use, a use or a method of treatment as claimed in Claim 30, wherein the symptoms of injury or disease include one or more of cough, dyspnea, shortness of breath, respiratory failure, pneumonia, fibrosis in one or more selected internal organs of the lungs, heart and / or kidneys.

32. A dosage form, use, or treatment method as defined in any one of Claims 19 to 31 (as applicable), wherein the treatment includes the prevention of morbidity and / or mortality in the relevant condition.

33. A dosage form, use, or treatment method as defined in any one of Claims 19 to 32 (as applicable), wherein the composition is administered orally.