Stein Formulation Of Drug Products

Proteins are polymeric chains that are built from monomers called amino acids. All structural and functional properties of proteins derive from the chemical properties of the polypeptide chain. There are four levels of protein structural organization: primary, secondary, tertiary, and quaternary. Primary structure is defined as the linear sequence of amino acids in a polypeptide chain. The secondary structure refers to certain regular geometric figures of the chain. Tertiary structure results from long-range contacts within the chain. The quaternary structure is the organization of protein subunits, or two or more independent polypeptide chains.

Saporin S6 is a compound that was isolated from the Saponaria officinalis, a plant known as soapwart. It has been studied for almost thirty years due to its unique properties in medical science. It is a protein that has had many studies done testing its potential application towards anti-tumor and anti-viral therapy. This particular article describes the reasons for its high stability towards denaturing agents. Protein are susceptible to denaturalization under specific conditions like temperature or the chemical environment that it is in. A protein’s structure also contributes to its stability. Researchers are looking at all the properties of this specific protein that allows it to remain its folding structure and function under abnormal conditions.

Many molecules, particularly peptides and polypeptides are physically embedded in polymers to create a complex network of interconnecting pores through which the drug could subsequently diffuse. The pore structure and polymer composition is controlled in order to design systems that release the drug at nearly any rate and for nearly

Sturmeny (2009) notes that clinical formulation is also known as case formulation as a fundamental skill for all clinical professionals in the mental health field. The primary purpose of the formulation is to assess the patient’s problem from a varied perspective and time span that helps in the diagnosis and treatment plan for the patient. The predisposing factors determine the vulnerabilities the patient is prone to; the precipitating factors evaluate the stress factors; perpetuating factors assess the maintaining factors while the predictive factors as the positive and the negative prognostic features of the problem (Fernando, 2010). The table below indicates the clinical formulation for Luis.

Another possibility is the process of disguising medically active molecules with lipophilic molecules that allow it to better sneak through the bbb, this is known as the pro-drug method. Another idea similar to the pro-drug method is peptide masking which masks the drugs chemical composition by masking a peptide's (a compound consisting of two or more amino acids linked in a chain) Characteristics by combining with other molecular groups that are more likely to pass through the bbb. An example of this is using a cholesteryl molecule instead of cholesterol that serves to conceal the water soluble characteristics of the drug. One of the most promising drug delivery systems is using nanoparticle delivery systems. These are systems where the drug is bound to a nanoparticle capable of traversing the bbb. The most promising compound for the nanoparticles is Human Serum Albumin (the most abundant protein in human blood plasma). The main benefits of this are that particles made of HSA are well tolerated and do not have any serious sided

Soon this idea began to be tested in laboratories, but being this was related to subject of bioengineering, different viewpoints arose very quickly. The subject of bioengineering composes of multiple views concerning particularly the cost and accessibility to bioengineering of these drugs and if the effort put in would equal the benefits. When looking at this it is evident that much more research and testing would need to be put in this field before true consideration for use in the pharmaceutical world. From there it is critical that a standard must be set for the production of all enzymes used in this process, making sure they are produced in abundance to ensure stability. Concerning the cost it is evident that production of this drug through chemoenzymatic means compares similarly to that of through pig intestines. Moreover the more steadfast way of producing heparin through chinese hamster ovary cells (CHOs) would most likely greatly exceed production through pig intestines. This would make CHOs used more in designer Heparin doses (Vaidyanathan, 2017). Other methods show some progress as well but they unfortunately present numerous challenges most likely impossible to

The Viscosity is optimum for 1.5% carbopol concentration since it has good flow and consistency unlike the 1% and the 2%, these both have either less or more viscosity compared to the optimum 1.5% carbopol. Viscosity of the optimized gel was found to have a range of 754-1350cp. Among which 1.5% concentration of carbopol gave good results of 1290±7cp. Determination of viscosity of gel matrix, is important as it assists in evaluating the penetration across the skin by controlling the release of the drug into the receptor medium. The same trend was observed by Lin et al., (2014) on the viscosity of apigenin ethosomes formulation [25].

The type of amino acid sample affected the ability of the reagents to react with the peptide bonds and amino acids. It also affected the amount of amino acids and peptide bonds in the protein. Each of the four proteins used in the experiment had the same concentration, which was reflected in the accuracy of the standards. In relation to the Bradford reagent, the amount of reactions that occurred depended on the amount of arginine and lysine amino acids present in the protein. In relation to the Lowry reagent, the amount of reactions that occurred depended on the amount of tryptophan and tyrosine amino acids in the protein and the number of peptide bonds linking the amino acids.

Although it was previously thought that cannabis was not a drug of addiction, it is now recognized that cannabis use can lead to substance dependence, according to the internationally accepted DSM-IV definition of ‘substance dependence’ .

Covalently linking the drug molecule directly to the antibody polypeptide chain, although intuitive, is not the most efficient method of synthesis. It is difficult to attach the drug molecule to a specific region on the antibody, frequently the molecule will attach at incorrect locations that significantly alter the immunoaffinity of the antibody. Furthermore, chemotherapeutic agents can be expensive to synthesize. Thus, any aberrant antibody that is discarded can be very costly. A simple, yet effective, solution to this problem involves the use of a linker molecule. In most cases it is more conducive if the bond between the payload and the linker molecule is weak, or cleavable, allowing for quick release. However, depending on the cell type, this lability is not always desired. We will discuss both methods of attachment in the following section.

The product, manufactured in state-of-the-art Food and Drug Administration (FDA) registered laboratories, is under the guiding principle of U.S. FDA’s cGMP

Although, the development of SC administration can present critical challenges, there is a common trend in the pharma industry to switch IV to SC. Currently, a few biologics already exist in the market as subcutaneous injection, including Enbrel (Amgen), Humira (AbbVie), Simponi (Janssen Biotech), and Stelaris (Janssen Biotech). (Doughty 2016) This change can be attributed to the emerging research and technology that can help facilitate the formulation of an IV to an SC protein delivery. Here, a comprehensive landscape is presented for the formulation adaptation of a protein biologic. The process of changing the route of administration of an IV injection to an SC injection is highlighted, as well as significant therapeutic and business benefits. Challenges involved in the process and possible

Proteins are the most abundant organic matter in living organisms. They have several functions such as; Structure, Movement, Transport, Buffering, Metabolic activity, Communication and Defence/Protection. (Creighton, 1989). Proteins are assembled using different structures known as Primary structures to Quaternary structures. The Primary structure of the protein is the sequence or order of amino acids in the polypeptide chain. Once several amino acids have joined together in a chain, the chain tends to make certain shapes or patterns. Peptide bonds contain polar hydrogen atoms (with a small positive charge) and polar oxygen atoms (with a small negative charge). This allows hydrogen bonds to form between peptide bonds in different parts of the chain. Because of this, the polypeptide chain can take on different shapes or patterns in different parts of the chain, and these patterns are called the Secondary Structure of the protein. The two main types of secondary structure in proteins are the alpha helix and the beta pleated sheet. The secondary structure of the protein depends on the amino acids it contains, and the order in which they join together. In other words, it depends on the primary structure. The Tertiary Structure of a protein is the overall three-dimensional shape. It has a specific shape and is held together by weak bonds between the side chains (R groups) of the different

Pharmaceutical formulations as prescription or over-the-counter medications are used to treat human and animal disease conditions (Thiele-Bruhn and Beck, 2005). Generally, drugs and other related compounds are biologically active and their molecular weights may range from 200 to 500 / 1000 Dalton. Currently, there is paucity of information on the total global administration of drugs to humans and animals. Despite the unavailability of data, sales in 2004 alone totaled $518 billion (Kümmerer, 2009). An increase to about $1.2 trillion by 2016 is expected due to the influence of merging markets, biologics and generics (IMS Health, 2012). Consequently, increased production, sales and ingestion of pharmaceutical chemicals (PHCs) may translate to higher residues in the environment. Typically, an ingested drug becomes metabolized and a part is excreted through urine and / or feces possibly in different forms. However, their removal during conventional wastewater treatments is inefficient because of their nature (Zuehlke et al., 2004; Daughton, 2007). Prescription (branded and non-branded) and over-the-counter medication are the major classifications of pharmaceutical products available to the United States (U.S.) population.

Based on United State Pharmacopeia, pastes are defined as semisolid dosage forms that contain one or more drug substances intended for topical application. (Pharmaceutical Dosage Form, 2009) Pastes are also intended for application to oral cavity or mucous membranes besides the skin. Pastes are usually prepared from fats, fatty oils, petrolatum, paraffin, waxes, glycerin or water by mixing homogeneously powdered drug with the foregoing materials as bases. (General Requirements for Pharmaceutical Preparation) There are two classes of paste which are fatty pastes and non-greasy pastes which is made from single phase aqueous gel.