In this study, the impact of agitated drying on the physical and bulk powder properties of an active pharmaceutical ingredient (API) is presented. The effects of different agitated drying conditions such as agitation rate, drying temperature, drying time pre-agitation, drying time during agitation and number of solvent wash cycles on the bulk density, millability, flow and specific surface area is reported. The crystal morphology is altered from fibrous needles to agglomerates when switching from tray to agitated drying. An increase in bulk density and specific surface area was evident when using agitated drying compared to tray drying as hard coarse granules were produced with an increase in the number of fine particles < 10 μm. The bulk density was found to increase with an increase in agitation speed, drying time and number of solvent wash cycles used during filtration. Controlling both fine and coarse particle size of the granules for this API during agitated drying was difficult to achieve due to the fibrous crystal habit. However, the increase in the bulk density observed has the potential to facilitate improvements in the ease of drug product development. In the case of this system further particle size control was required through the use of dry milling.

Understanding the phase behavior of crystal forms is essential in drug formulation development, as physical stability of the active pharmaceutical ingredient (API) is critical to achieving the desired bioavailability. Solvents greatly impact the physical stability of crystalline solids, resulting in a variety of well-known phase transitions, such as hydrate/solvate formation. However, solvent incorporation may also result in the formation of a less-known crystalline solid solutions (CSSs). The identification and characterization of CSSs and their effect on API physicochemical properties have not been investigated. This is the first reported instance of a CSS for an API. An exhaustive study of the phase behavior of the enantiotropically related polymorphs, I and II, of Benzocaine in water and ethanol revealed that Form I formed a CSS with water below 294.5K. Construction of the phase diagrams of Forms I and II in water and ethanol revealed that CSS formation significantly decreased the phase transition temperature between Forms I and II in water. This change resulted from the increased disorder in the lattice of Form I due to the presence of water. This work demonstrates the importance of understanding the formation of CSSs on the thermodynamic behavior of crystalline pharmaceutical solids.

Active Pharmaceutical Ingredient-Ionic Liquids (API-ILs) draw increasing interest as a particular class of ILs that possess unusual physicochemical properties along with simultaneous potentials for pharmaceutical applications. Although nanostructuring phenomena were actively investigated in common ILs, their studies in API-ILs are scarce so far. In this work, using the complex methodology of Electron Paramagnetic Resonance (EPR) and dissolved spin probes, we investigate nanostructuring phenomena in a series of API-ILs: [Cnmim][Ibu], [Cnmim][Gly], and [Cnmim][Sal] with n = 2, 4, and 6, respectively. We reveal similar trends for API-ILs and common ILs, as well as peculiarities inherent to the studied API-ILs. Unusual behavior observed for [Cnmim][Ibu] has been assigned to the presence of a non-polar fragment in the [Ibu]− anion, which leads to the formation of more complex nanostructures around the radical compared to common ILs. Understanding general trends in the formation of such self-organized molecular structures is of fundamental interest and importance for applying API-ILs.

This review seeks to offer a broad perspective that encompasses an understanding of the drug product attributes affected by active pharmaceutical ingredient (API) physical properties, their link to solid form selection and the role of particle engineering. While the crucial role of active pharmaceutical ingredient (API) solid form selection is universally acknowledged in the pharmaceutical industry, the value of increasing effort to understanding the link between solid form, API physical properties and drug product formulation and manufacture is now also being recognised. A truly holistic strategy for drug product development should focus on connecting solid form selection, particle engineering and formulation design to both exploit opportunities to access simpler manufacturing operations and prevent failures. Modelling and predictive tools that assist in establishing these links early in product development are discussed. In addition, the potential for differences between the ingoing API physical properties and those in the final product caused by drug product processing is considered. The focus of this review is on oral solid dosage forms and dry powder inhaler products for lung delivery.

Metabolic related diseases such as cancer, diabetes mellitus and atherosclerosis are major challenges for human health and safety worldwide due to their associations with high morbidity and mortality. It is of great significance to develop the effective active pharmaceutical ingredient (API) delivery systems for treatment of metabolic diseases. With their unique merits like easy preparation, high adjustability, low toxicity, low cost, satisfactory stability and biodegradation, deep eutectic solvents (DESs) are unarguably green and sustainable API delivery systems that have been developed to improve drug solubility and treat metabolic related diseases including cancer, diabetes mellitus and atherosclerosis. Many reports about DESs as API delivery systems in the therapy of cancer, diabetes mellitus and atherosclerosis exist but no systematic overview of these results is available, which motivated the current work.

Active pharmaceutical ingredient is a chemical compound which is most important raw material to formulate a finished pharmaceutical medicine and has a pharmacological effect. India has a long history of being heavily dependent for these raw materials on China due to one major reason i.e. Low manufacturing cost. But overdependence of APIs imports from China brought various liabilities to India including supply chain disruption and price hikes during pandemic, leading to shortage of various important APIs/KSMs. This COVID 19 widespread has solidly put the center of our country on being “Atma Nirbhar”. And this activity had brought out the strengths, market patterns and opportunities in five divisions counting Healthcare, which are basic from country’s point of view. In view of changing geo-political situation and recalibrated trade arrangement, it is crucial that India become self-reliant within the generation of APIs and KSMs, which is why decreasing the Import reliance for Active pharmaceutical ingredients (APIs) &amp; Key starting materials (KSMs) particularly from china has been focused upon with the assistance of productive linked incentive scheme (PLIS) passed by Department of pharmaceuticals, Government of India to thrive Indian API industry.&#x0D; Hence, this review highlights the current state of Indian API industry, evaluates challenges, opportunities give suggestions for moving forward for self-sufficiency of APIs as well as centers on current regulatory prerequisites for Active pharmaceutical Ingredients.

API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. For example, an active ingredient to relieve pain is included in a painkiller. Developing and producing Active Pharmaceutical Ingredients (APIs) includes various processing steps, such as reaction, crystallization, separation and purification, solvent swap, and solvent exchange. Active Pharmaceutical Ingredients or APIs are also known as bulk drugs and a term that is often heard in business news. An active ingredient is the ingredient in a pharmaceutical drug or pesticide that is biologically active. The similar terms active pharmaceutical ingredient and bulk active are also used in medicine, and the term active substance may be used for natural products. Active Pharmaceutical Ingredients are the active ingredients contained in a medicine. The issue of disposal of wastes from these API companies, as well as the development and implementation of efficient collection strategies, is an important concern. This research looks into the factors that have an impact on the disposition of wastes from these companies, and how are these addressed by local government bodies. The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs.

This paper highlights the benefits resulting from the application of double active pharmaceutical ingredient in ionic liquids as active pharmaceutical ingredients (APIs). Double active pharmaceutical ingredient benzalkonium ibuprofenate with anti-bacterial and anti-inflammatory roles, which offers high solubility, bio-availability, and biological activity. Structure and vibrational properties of NaIb, BaCl, and synthesized BaIb have been studied using Density Function Theory and are in good agreement with the experimental results of FTIR, UV–Visible, and NMR. The thermal and spectroscopic investigation using differential scanning calorimetry (DSC) and broadband dielectric spectroscopy (BDS) revealed different phases of BaIb and disclosed the synthesized API is an excellent glass former. The glass transition temperature Tg=194.14K and fragility index m=68.58 were estimated and compared with other members of the profen's family by Vogel–Fulcher–Tamman (VFT) equation. Finally, the in vitro and in vivo biological activities of the synthesized drug BaIb were done along with the parent drugs NaIb and BaCl as a control to ensure the double active effect.

Physical characteristics of an active pharmaceutical ingredient (API) can have a significant impact on the processability of a high drug loading formulation. This paper provides an example where different micromeritic properties of an API were obtained by crystallization under different conditions, resulting in different tableting behavior. While the API form purity was maintained during the crystallization process change, significant changes were incurred in the surface geometry, porosity and surface area of the API. The batches consisting of particles with greater surface irregularity and porosity gave tablets of higher mechanical strength.

Active pharmaceutical ingredient (API) purity is of major concern for pharmaceutical companies and the medical community. Reaching ultralow limits of genotoxic impurities (GTIs), imposed by strict legislation, is often time consuming and economically challenging. Therefore, there is a call for efficient unit operations able to remove GTI with minimal API losses from the organic solvent postreactional streams. This study reports for the first time a new approach to improve the performance of polybenzimidazole (PBI), a solvent-stable polymer, to efficient GTI removal. Two families of GTIs are considered, and the discovery that the use of specific thermal and pH conditioning of PBI adsorbers improves GTI removal efficiency is reported. Electrospun fibers are explored, aiming at process versatility. Similar removals of GTI, more than 97%, are achieved with virtually no API loss.