Drug Formulation: The Complete Pharmaceutical Guide

Drug formulation refers to the process of developing a drug product that contains a specific volume of an active pharmaceutical ingredient (API) and other necessary factors in a form suitable for administration to patients.

Importance of Drug Formulation

The formulation process is critical to the pharmaceutical industry for several reasons:

Enhancing Drug Efficacy

Formulation helps optimize the drug's therapeutic effect and ensure its safety by developing a product that delivers the active component effectively while minimizing adverse effects.

Ensuring Patient Compliance

Formulations are designed to make medicines easier to administer and improve treatment adherence.

Expanding Market Opportunities

Different formulations can target different patient populations, improving access to treatment.

Patent Protection

New formulations can extend patent protection, providing additional exclusivity.

Drug Formulation Development Process

1. Pre-formulation Studies

Characterization of the API's physicochemical properties to identify the most suitable form for formulation.

2. Formulation Design and Optimization

Developing a stable, bioavailable formulation that meets quality, safety and efficacy requirements.

3. Drug Delivery Systems

Designing systems to optimize delivery and improve compliance through various administration routes.

Types of Drug Formulations

Solid Dosage Forms

Tablets, capsules, powders, granules, and sustained-release formulations.

Liquid Dosage Forms

Solutions, suspensions, emulsions, and syrups.

Semisolid Dosage Forms

Creams, ointments, and gels for topical application.

Manufacturing Challenges

Key challenges include maintaining consistency, controlling costs, scaling up production, and ensuring regulatory compliance with GMP standards.

Regulatory Aspects

FDA regulations, Good Manufacturing Practices (GMP), and compliance requirements govern drug formulation to ensure safety and efficacy.

Future of Drug Formulation

Advancements in technology will enable more personalized and precision medicines through innovative delivery systems and targeted therapies.

Understanding the Impact of Rising API Costs on Drug Pricing

The SME Pharma Industries' Confederation (SPIC) has said that considering the rising cost of active pharmaceutical ingredients (APIs) and excipients, the maximum price tags of medications should be adjusted according to the changing ingredient cost periodically.

In recent months, the cost of bulk drugs has increased significantly. For instance:

• Paracetamol: Increased from ₹350/kg to ₹900/kg
• Carbamazepine: Rose from ₹2,000/kg to ₹5,500/kg
• Ceftriaxone sterile: Increased from ₹6,600 to ₹8,200
• Tazobactam: Jumped from ₹47,000 to ₹55,000

The maximum price tags for drugs have not been adjusted promptly by the National Pharmaceutical Pricing Authority (NPPA), even when the cost of raw materials exceeds the fixed price of the drug. This lack of adjustment has led to quality concerns in the industry.

"Currently, the situation is the worst it has ever been. Legitimate manufacturers are losing market share," said the secretary general of SPIC in a letter to Prime Minister Narendra Modi. The association has consistently warned about over-reliance on China for APIs.

Bulk pharmaceutical wholesalers have been stockpiling raw materials to profit from price hikes, with no government policy to curb this behavior. The Central Drugs Standard Control Organization (CDSCO) could help address this issue.

"Unless API costs are brought under price control, medication prices should fluctuate with API costs. The government must act to ensure affordable quality generics," the SPIC representative concluded.

The Rise of Turkish Pharmaceutical Companies

Turkey’s Ambition to Become a Global Medicine Hub

Turkey is eager to become a global pharmaceutical center due to its strong production capabilities, strategic location, demographics, and robust infrastructure, according to Savas Malkoc, General Secretary of the Pharmaceutical Manufacturers Association of Turkey (IEIS).

Pharmaceutical Industry Overview

With 100 pharmaceutical and 11 raw material manufacturing facilities, 680 organizations, 33 R&D centers, and over 11,000 employees, Turkey's pharmaceutical sector is producing more than 12,000 products. As of 2020, 88% of pharmaceuticals consumed in Turkey are produced locally.

Strategic Advantages of Turkey’s Pharma Sector

Turkey’s pharmaceutical industry benefits from its favorable geographical location, connecting some of the most dynamic pharmaceutical markets worldwide. In 2020, the Turkish pharma market was the 18th largest globally, with exports reaching nearly 180 destinations, including the European Union, Commonwealth of Independent States (CIS), North Africa, East Asia, and the Middle East.

Challenges and Opportunities in the Turkish Pharma Market

Despite challenges posed by the COVID-19 pandemic, the Turkish pharmaceutical sector continued operations without significant disruptions. Turkey has also started producing medicines used in COVID-19 treatments, which were previously not manufactured locally. Biotechnological products are also gaining momentum in Turkey, with biotechnological drug demand reaching 25% of the total Turkish pharma market in 2020.

Research and Development in Turkey's Pharmaceutical Industry

R&D investments have seen significant growth, reaching 423.8 million liras ($88.3 million) over the past five years. Turkish companies have developed innovative pharmaceuticals, such as sustained-release formulations and combination products that improve patient adherence.

Future Outlook and Biosimilars

Turkish companies are increasingly focusing on producing biosimilar drugs with plans to launch 39 biosimilar products by 2024. To support this growth, a stable regulatory environment is necessary for Turkey to compete effectively on a global scale.

© 2024 Turkish Pharmaceutical Industry Insights. All Rights Reserved.

Emzor Partners for Local Malaria API Manufacturing in Nigeria

Emzor has signed an API Manufacturing Technology Transfer and Licensing Agreement with India's Mangalam Drugs and Organics Limited to locally fabricate in Nigeria and convey Active Pharmaceutical Ingredients (APIs) for the treatment and prevention of malaria.

The course of action incorporates an API innovation move and permitting arrangement, which builds up a co-advancement reason for assembling 4 APIs for the treatment of malaria, which continues to be a main source of death on the African continent.

This will prompt the improvement of an elite API fabricating office in full compliance with worldwide standards and the first of its kind in the sub-Saharan African region.

The arrangement reaffirms Emzor's long-standing commitment to strengthening the pharma sector in Africa. The marked technology transfers and licensing agreement with Mangalam, a leading Indian substance manufacturing company, will provide in-house developed technology for manufacturing antimalarial Active Pharmaceutical Ingredients (APIs).

As part of the arrangement, Mangalam will also provide consultation and relevant plans for setting up an elite API manufacturing office compliant with WHO standards. The initial focus will be on the development of 4 APIs: artemether, lumefantrine, sulfadoxine, and pyrimethamine.

The selected APIs provide chemo-preventive combination treatments for malaria in pregnant women as well as treatment for adults and children. Malaria remains the leading cause of death in Nigeria.

According to the 2020 World Malaria Report, Nigeria had the largest number of global malaria cases (27% of global malaria cases) in 2019 and accounted for the highest number of deaths (23% of global malaria deaths).

Emzor is a pioneer in the Nigerian malaria space and was the first Nigerian indigenous pharmaceutical company to develop and manufacture artemether/lumefantrine, under the brand name Lokmal, launched in 2009.

Artemether/Lumefantrine is a WHO-recommended Artemisinin Combination Therapy (ACT). Maldox is Emzor's brand name for its sulfadoxine and pyrimethamine (S/P) combination antimalarial.

Emzor is at an advanced stage in the process of submitting a dossier to WHO prequalification for Maldox, a project supported by Medicines for Malaria Venture (MMV) with funding from UNITAID.

Emzor currently manufactures 19 SKUs of antimalarials, and this continued focus and strategy build on Emzor's strength in maternal and child health. It solidifies the company's commitment to impacting the therapeutic areas that most greatly affect this vulnerable segment of society.

The arrangement addresses a remarkable opportunity for local manufacturing and backward integration, which supports the company's vision to reduce the cost of medications and the supply chain issues often affecting distribution and global response, especially in the midst of crises such as the COVID-19 pandemic.

Moreover, this agreement with Mangalam is a timely response to the total reliance on external firms for APIs to support the regional pharmaceutical industry.

The successful launch of such an initiative will require various collaborations, so we are also pleased to partner with API For Africa (APIFA), a non-profit organization working on local API production in sub-Saharan Africa.

Dr. Stella C. Okoli, Emzor's Founder and Managing Director, said, "We give God all the glory and praise Him for this great opportunity to serve Nigerians, Africans, and humanity.

This arrangement is exciting for us as it gives Emzor a chance to become a leader in the global fight against malaria and contributes to our strong commitment to bringing affordable medicines for all.

The arrangement is not just a victory for Emzor; by being able to manufacture at this level locally, in time, we will drive the expansion of our national chemical industries, provide opportunities to utilize the petrochemical industry for creating key starting intermediates, create local jobs, and reduce the cost of medications for those who need it the most.