Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When designing pharmaceutical preparations, the choice of excipients should not only consider the dosage form factors and excipient functions but also the interaction and compatibility between APIs and excipients.
Therefore, during the research and development process of pharmaceutical preparations, comprehensive and reliable interaction studies are essential. These studies not only serve as a foundation for dosage form screening and design but also generate research insights for the improvement of pharmaceutical products.
Common preparations include tablets, solutions, granules, pills, and similar forms. Excipients can serve as lubricants, disintegrants, antioxidants, and binders. While formulating commonly used preparations, it's vital to examine the compatibility between APIs and excipients to select excipients that do not adversely effects the drug.
Solid Dosage Forms
Interactions between drug substances and excipients in solid dosage forms involve both physical and chemical interactions. The former can induce changes in the appearance, odor, solubility and polymorphic form of the drug. Chemical interactions with excipients generally result in drug degradation or the formation of impurities that adversely affect drug stability and safety. Recent studies have shown that chemical reactions in pharmaceutical preparations may occur not only between APIs and excipients but also between APIs or excipients and their impurities. The extent of chemical reactions is influenced by factors such as the present form, water content, pH, light, oxygen, etc.
In compatibility studies, APIs and excipients are usually mixed at 1:1 ratio to maximize contact between excipients and drugs, increasing the probability of interaction reactions. However, in recent years, scientists have also found that interactions in pharmaceutical preparations may be affected by the actual preparation process of APIs and excipients.
Liquid Dosage Forms
In liquid dosage forms, physical or chemical interactions between APIs and excipients can exert either beneficial or detrimental effects on product quality. For example, some studies reveal that the nonionic polymer hydroxypropyl methylcellulose can adsorb onto the pyrimidine pamoate particles' surface, forming an adsorption layer that prevents drug particle aggregation in space. At the same time, this alters the zeta potential of the drug particles, making the suspension more stable. Jin Wei et al. reported that adding disodium edetate to the carboplatin injection formulation accelerates carboplatin degradation and produces platinum-containing impurities such as 1,1-cyclobutanedicarboxylic acid and ethylenediaminetetraacetic acid disodium, leading to drug safety concerns.
In addition, soluble and ionizable excipients can interact with ionizable drug substances in liquid systems, resulting in insoluble precipitate formation. Sodium alginate and sodium carboxymethylcellulose, which are water-soluble, can generate numerous negatively charged ions that precipitate with positively charged neomycin and polymyxin. Bentonite (negatively charged) and stevensite (positively charged) are excipients derived from minerals that interact with oppositely charged drugs. Variations in aqueous media can also impact API stability in liquid formulations. Captopril, for instance, displays poor stability in aqueous media. Under high humidity conditions, trace metals present in excipients catalyze its oxidation to form captopril disulfide. However, due to the presence of ionic species that interact with metals and can accelerate the degradation of captopril, mineral water is more conducive to maintaining drug stability than distilled water.
Carrier-Based Formulations
To address issues related to inadequate solubility, stability, and bioavailability, APIs and excipients can be incorporated into carrier-based formulations such as clathrates, co-crystals, solid dispersions, phospholipid complexes, and microparticulate drug delivery systems. These are collectively referred to as carrier preparations. In recent years, research on drug-excipient interactions has expanded to include the influence of excipients on the formation of excipient formulations and interactions between different excipients. Such research significantly influences formulation design and optimization.
According MarketsandMarkets Research – The Global Superdisintegrants Market is projected to reach USD 536.5 million by 2023 from USD 366.4 million in 2018, at a CAGR of 7.9% during the forecast period.Growth Opportunity: Pharmaceutical market expansion in emerging countries;The traditionally lucrative pharmaceuticals market is becoming challenging from a growth perspective due to the diminishing drug pipeline, government pressures to curtail healthcare costs, and the increasing regulations on innovative products.
This is encouraging pharmaceutical manufacturers to move their manufacturing bases closer to high-growth emerging markets.
Through this, manufacturers can take advantage of the low-cost manufacturing along with several financial benefits in terms of attractive tax rates and lenient regulatory guidelines for manufacturing in these countries.
A number of major excipient manufacturers are either planning capacity expansions of their existing plants in emerging countries or setting up new manufacturing plants in emerging markets such as China and India.Market Growth Drivers;# Growing Adoption of Orally Disintegrating Tablets# Growing Generics Market# Emergence of New Superdisintegrants for the Pharmaceutical IndustryRequest Research Sample Pages: https://www.marketsandmarkets.com/requestsampleNew.asp?id=198068672Leading Key Players in the Worldwide Industry:The prominent players in the global superdisintegrants market are Ashland Inc. (US), BASF SE (Germany), DowDuPont (US), JRS Pharma (Germany), DFE Pharma (Germany), Roquette Freres (France), Asahi Kasei Corporation (Japan), Merck KGaA (Germany), Corel Pharma Chem (India), and Avantor Performance Materials, LLC (US).Geographical Regions Mapped in Report:Europe is expected to account for the largest share of the superdisintegrants market in 2018, followed by North America and Asia Pacific.
The large share of this region can be attributed to the presence of a number of pharmaceutical giants with large production capacities leading to high consumption of excipients.
Moreover, a number of major global players are based in Germany.Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=198068672Market Segmentation in Detailed:Based on formulation, the superdisintegrants market is segmented into tablets and capsules.
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Pharmaceutical products have grown in demand in recent years due to the growing prevalence of chronic and lifestyle diseases such as diabetes and cardiovascular diseases.
The growing healthcare sector in emerging regions such as Asia Pacific is likely to be a major driver for the sterile medical packaging market over the forecast period.
This has led to a growth in the medical devices industry, as increasingly advanced and sophisticated medical devices have come in use in these regions.
Adoption of medical packaging in Romania, Turkey, and Poland offers significant growth prospects.
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Of these, the liquid segment will have the largest share in the market over the forecast period.
Of these, the fibromyalgia segment will dominate the market over the forecast period on account of the rising incidence of physiological disorder, particularly in young adults.
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Fabry Disease Market Research Report: by type (type-1 and type-2), diagnosis & treatment (diagnosis (blood test, urine test, imaging, others, treatment (Enzyme Replacement and Gene Therapy, Anticonvulsants, others))), by end user - Global Forecast Till 2027Market Highlights:The Global Fabry Disease Market is expected to grow at a CAGR of 6.8% during the forecast period.
Technological advancements, strong pipeline, advancements in healthcare facilities, and favorable funding policies are expected to drive the market growth over the forecast period.
Owing to the increasing awareness about Fabry disease, new and existing market players are coming up with better treatment approaches.
For instance, in 2018, 2018, Amicus Therapeutics launched Galafold capsules 123mg for the treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.However, diverse range of symptoms, and related complications can restrain the market growth over the assessment period.Regional Analysis:Geographically, the Americas is expected to dominate the global market owing to the increasing technological advancements and rising research and development activities.
So, for the advanced treatment of these patients SmartPill testing procedure is developed to gain additional understanding of Fabry disease manifestation via motility abnormalities in order to improve symptom targeted therapy.
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The key players in the fabry disease treatment market include Abbvie Inc., Amgen Inc., Bristol-Myers Squibb Company, Genzyme Corporation, GlaxoSmithKline Plc, Ibio, Inc., Inc.
