Question 1:  Could you describe AmWiner Raphegenerics Biopharmaceutical company in summary?

AmWiner Pharmaceutical, now known as RapheGenerics Corporation, has expanded its operations to include manufacturing a wide range of pharmaceutical products. These include low-cost, high-quality interventions such as biologics, injectable prescriptions, over-the-counter medications, tropical treatment medicines for Malaria, suppositories, peptides, and personalized compounded medications for commercial distribution. We brought affordable, high-quality store-brand generic medicines and well-being drug products to the medical system by manufacturing store-brand generic medications, both OTC and prescriptions, at low cost to help consumers who could not afford the high cost of name-brand medications afford the care they need and alleviate pain and suffering in humanity.

 We are based in Dallas, TX, with one location in Isreal and South Africa, and offer private label and contract manufacturing of sustainable, low-carbon-footprint drug products, Transdermal Patch drug products, Clean Beauty skincare, analgesics, hair care, and personal care products. We private label many dermatological products for effectively managing acne, pigmentations, Cold Flu, Contraceptives, Ora solid and Liquid OTC dosages, and natural hair loss treatments sold under retail store brand names. Our products are FDA-registered, WERCS-OSHA-certified, and compliant with California Prop 65. Our trademark brand is called Raphe Pharmaceutique Laboratories.

Question 2: So many pharmaceutical manufacturers provide the same services as you; what sets you apart from your competitors or others?

 What makes our industry unique and sets us apart from others is the Problem we are solving in healthcare and pharmaceutical manufacturing systems.

Question 3: What are the problems?

 The challenges in pharmaceutical drug formulation have increased significantly in recent decades while the market situation has grown increasingly challenging. New chemical entities in the pipeline face solubility challenges, with about 80 percent reported as having poor solubility. Since formulation solubility is a critical prerequisite for good bioavailability and therapeutic efficacy, finding ways to improve solubility without changing the chemical nature of the NCE has never been more crucial.

In addition, industry trends toward regionalization and personalization of treatment approaches necessitate faster, more efficient, and increasingly flexible solutions. As a result, continuous pharmaceutical manufacturing is currently a prominent field of development, driving the need for tighter process controls and more thorough process and product understanding.

Drug formulation development challenges for small biopharmaceutical companies are becoming increasingly crucial as drivers of innovation in drug development. It has recently been estimated that most drugs currently in development are in the hands of small biopharmaceutical companies. Formulation is one of the most crucial parts of the drug development process. We must be able to deliver the drug to the body in whatever dosage form is necessary to provide the best effect for that medication. Without proper formulation that guarantees solubility and bioavailability, patients’ health and healthcare will be at tremendous risk. Small pharmaceutical drug companies want to develop formulations for clinical trials quickly, but they have reduced resources and technology challenges to develop the most cost-effective formulation as soon as possible. The quicker the medication can reach patients, the faster we can positively impact the world's healthcare system.

The two parameters, time and cost, are the biggest challenges in formulation development, especially for small molecules. This means how well that formulation releases the molecule and how well that molecule passes from the gastrointestinal tract into the systemic circulation will determine the therapeutic outcome. This process is less efficient when drug solubility is reduced. What we've seen over the past decades is that the solubility of drug molecules has been decreasing every year and that up to 80% of the drugs in the drug development pipeline are poorly soluble. Poor soluble drugs in the system mean longer patient recovery time.

Small pharmaceutical companies have used a variety of approaches to address these drug formulation challenges, including the use of new technical platforms and the use of new formulations or technologies that enhance the actions of known drugs. One example is a new, thermostable polymer for hot-melt extrusion processes that combines stabilization of the solid amorphous form in the tablet and inhibiting drug precipitation in dissolution. Another formulation technology is a silica-based drug carrier with a functionalized particle structure that allows API adsorption onto its surface and pores, stabilizing the drug in a soluble amorphous form. These two methods have yet to yield definitive success, and there is a need for intelligent technology capable of guaranteeing effective formulation that will help strengthen and improve our healthcare system and patients' well-being.

An intelligence technology having access to a wide range of suitable excipients is a prerequisite for a successful formulation approach. This is where we come in.

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Question 4: What solution do you offer?

 We have transformed the pharmaceutical industry in drug development and patient care by integrating artificial intelligence technology in medicine development and efficacy testing. This technology will revolutionize how drug products are formulated, dosed, and tested for stability, purity, and efficacy.

Understanding intelligence Technology in Drug Development or Formulation is a field of artificial intelligence in which software learns from imputed data to perform a task throughout the drug development and manufacturing process that will increase drug efficiency and effectiveness, decreasing the time and cost required to bring new drugs to market, and allowing small pharmaceutical companies to be part of the manufacturing process of bringing new medicines with optimum solubility and bioavailability to the market and increasing the supply of the existing ones. These improvements will save lives and reduce suffering by getting drugs to patients in need more quickly and could allow researchers to invest more resources in rare or orphan diseases.

Question 5: How does your technology improve the healthcare system?

AmWiner Formulation Technology significantly enhances medicine development by taking the guesswork out of every formulation. The chemist/pharmacist will know with 100% certainty the best and accurate percentage of Active Pharmacological Ingredient/s and expedient percentages to use his/her formulation that will yield the desired expected results, taking the human error of miscalculation that contributes to some adverse effects. When confronted with a custom formula, you`re confident that the technology will determine the accurate percentage of the active and expedients needed to use based on the imputed objective you intend to achieve. Even when you add more or less of what is required, the “Pharmacy formulation technology” will indicate which ingredient/s you have in excess and how to balance your formulation, expediting the formulation and optimizing the dosages.

Advanced technology algorithms for pharmaceutical industries should be used to analyze the finished product to produce a more accurate certificate of analysis and SDS document and conduct stability product testing, shelf-life testing, and efficacy testing. AmWiner's “formulation technology” takes the guesswork out when conducting Quality control testing on solid oral dosage tablets/capsules, friability tests, tablet disintegration tests, dissolution tests, and moisture content tests. A power engineer would use this tool in tablet coating when manufacturing XR or enteric-coated pills. It should determine the exact percentage of the coating ingredient required and show the best coating substance suitable for each tablet moiety. You (the chemist) can take the drying and chipping issues of the coating process out of your list of worries because this technology delivers a 100% accurate coating technique and guide for your OSD batches.

Question 6: Does your technology have any relevance to patient care?

 Our technology is such that it collects vast amounts of data related to human biology, dermatological conditions, and ingredient interactions to identify potential compounds, ingredients, and therapeutic interventions necessary for every skincare or bodily concern. This accelerates the research and development phase and enables the creation of highly effective and personalized solutions. Moreover, these algorithms will predict the performance of different formulations, creating products that offer superior outcomes in addressing various patients’ skin concerns.

Question 7: How would it help pharmaceutical Research and Drug Development?

 Integrating AmWiners technology in pharmaceutical product development facilitates the identification of novel compounds with therapeutic potential. These algorithms will pinpoint promising treatments for skincare or bodily issues by analyzing molecular structures and biological pathways, thus streamlining the therapeutic process. This approach will open new avenues for developing innovative therapies for common skin and body ailments, such as acne, vitiligo, rosacea, pigmentation, eczema, and aging-related conditions, and enable researchers to assess the safety and efficacy of potential drug products, fostering the creation of products that are not only effective but also safe for prolonged use.

AmWiner technology revolutionizes pharmaceutical drug development by empowering researchers to navigate the complexities of human biology and formulation optimization with unprecedented speed and precision. The insights generated by the algorithm will pave the way for creating next-generation drug products that cater to diverse health conditions, marking a paradigm shift in dermatology and general medicine.

What is the Role of AmWiner Formulation Technology in Medicine Dosing, or does it play any role in Medicine Dosing?

 Yes, it does.  In drug product development, accurate dosing is paramount to ensure optimal therapeutic outcomes and minimize adverse effects. It is pivotal in precision dosing by leveraging data analytics and predictive modeling to determine the most effective dosage regimens for any drug product. By analyzing patient-specific factors, such as skin type, age, and medical history, the AmWiner AI algorithms can tailor dosing recommendations to individual needs, thereby enhancing the efficacy and safety of treatments. This technology will adapt to real-time changes in patient responses and adjust dosage parameters accordingly. This dynamic dosing approach will enable healthcare professionals to fine-tune treatment plans based on evolving patient conditions, ultimately optimizing the therapeutic benefits of the medicines. The algorithms will also identify potential drug interactions and contraindications, offering valuable insights to healthcare providers and patients.

By harnessing the power of AmWiner intelligence technology in medicine dosing, the pharmaceutical industry is poised to deliver personalized treatment regimens tailored to everyone’s unique physiological and dermatological profile. This not only maximizes the efficacy of the drug product but also minimizes the risk of adverse reactions, setting a new standard for precision and safety in dermatological care.

 Does it apply to drug and quality control testing?

 Yes, utilizing this technology in Product Stability Testing ensures the stability of any drug product, which is essential to maintaining its efficacy and safety over time. This technology emerges as a game-changer in product stability testing, enabling manufacturers to assess the impact of various environmental factors, storage conditions, and formulation changes on the shelf-life and performance of skincare products. Through predictive modeling and accelerated testing methodologies, the algorithms will predict the degradation kinetics of active ingredients, anticipate potential formulation instabilities, and optimize packaging materials to prolong product shelf-life.

The AmWiner-powered stability testing moiety rapidly identifies formulation modifications that enhance product stability without compromising efficacy. By simulating different storage scenarios and analyzing real-time data from stability studies, these algorithms will recommend adjustments to formulation parameters, packaging designs, and storage protocols to mitigate degradation risks and extend the lifespan of drug products. This proactive approach to stability testing minimizes product wastage and ensures consistent efficacy throughout the product's shelf-life, thereby enhancing customer satisfaction and brand reputation.

Furthermore, it facilitates the early detection of stability issues by flagging potential risks based on predictive analytics and historical data. This proactive monitoring capability will empower drug product manufacturers to preemptively address stability concerns, implement corrective measures, and maintain the integrity of their products throughout their lifecycle. As a result, AI-driven stability testing not only streamlines the product development process but also fosters the creation of high-quality drug products that meet stringent stability and performance standards.

In conclusion, what would be your technology's paramount benefit to small businesses manufacturing drug products?

 Incorporating AmWiner formulation technology in product development is the best recommended practice. To maximize these benefits, compounding pharmacists and chemists will prioritize data quality and diversity, ensuring that the algorithms collect comprehensive datasets encompassing various demographics and dermatological conditions. This inclusive approach to data collection and analysis will foster the creation of effective drug products across diverse populations and demographics, promoting inclusivity and accessibility in healthcare systems. Drug product developers can leverage diverse expertise to optimize formulation strategies, dosing protocols, and efficacy testing methodologies by fostering partnerships between dermatologists, pharmacologists, data scientists, and AI experts. This collaborative approach enriches the insights generated by the AI algorithm and ensures that drug products are developed with a comprehensive understanding of human biology, therapeutic mechanisms, and patient needs.

Continuous validation and refinement of the Amwiner formulation technology models are critical to maintaining the accuracy and reliability of drug development processes. The chemist or bio pharmacist will regularly validate the algorithms against real-world clinical data, patient outcomes, and market feedback to ensure that the insights and recommendations offered by AmWiner Pharmacy formulation technology” remain aligned with actual patient needs and treatment outcomes.

These are what sets our industry apart from others. For more information or to find out more about how we can help your practice or business, contact us at 469-428-5508