Development of a successful pharmaceutical formulation requires the combination of the active pharmaceutical ingredient API with inactive excipients. Excipients may be simple bulking agents, designed to aid control of the dose content uniformity. Increasingly, though, some excipients have a functional role in controlling drug release or ensuring the drug reaches the desired site of action. Here, compatibility between the selected excipient and the drug substance is critical in ensuring the correct dose is delivered within the required therapeutic window.
Physicochemical analysis can aid excipient selection, enable the stability of the drug substance and drug product to be assessed, and also ensure the critical material attributes CMAs relating to formulation performance are identified as part of the design space definition applied for downstream manufacturing controls.
The Zetasizer Ultra can characterize the stability and quality of dispersions, emulsions and creams, reducing formulation time and speeding new products to market. The increasingly complex requirements for achieving reproducible drug delivery are a common challenge for formulation development scientists. Many new active pharmaceutical ingredients APIs are poorly soluble, meaning that traditional oral solid dose delivery is no longer relevant.
Formulation complexity is therefore increasing, either to enable increased bioavailability for oral administration, or to enable local delivery so that the drug concentration at the site of action meets therapeutic requirements. Novel drug delivery systems, based on liposomes or other nanoparticle delivery systems, are being utilized more frequently to improve drug targeting.
This aids the optimization of complex formulations, saving time in selecting an effective candidate formulation. The challenges of developing complex formulations also extend to the development of generic drug products. Regulators around the world have recognized the impact of a lack of successful complex generic product introductions on healthcare costs.
In response, they have released product-specific guidance which highlights the role of assessing physicochemical, or Q3, equivalence as part of the evaluation of the bioequivalence of a test generic product compared with a reference listed drug RLD product. Application of an in vitro bioequivalence testing approach has the potential to significantly reduce the time to market for new generics by removing the need for clinical endpoint studies. This webinar will consider the workflows associated with evaluation of physicochemical Q3 bioequivalence with reference to the measurement solutions offered by Malvern Panalytical.
Development of a sucessful generic formulation starts with an understanding of the structure and performance of the reference listed drug RLD product. Here, as in in vitro bioequivalence assessments, physicochemical analysis has an important role to play in advancing the understanding of pharmaceutical formulation requirements.
Proactive, quantative, structural and morphological characterization of the API and excipients present within the RLD product can prototype formulation optimization and significantly reduce development risks. The benefits of this deformulation approach are not limited to generics companies. Similar methods are also applied in the development and manufacture of new drug products, providing insight to help pinpoint the root cause of changes in formulation performance during scale-up.
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Please click here to request a quotation for your drug manufacturing project Emerging biotechnology companies planning their early phase clinical trials seek to use contract development and manufacturing organizations CDMOs in order to meet their particular Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website.
These cookies do not store any personal information. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics. Formulation Development. What is drug formulation? Why is drug formulation development important? Most Important Considerations in Drug Product Development What aspects should be considered at the beginning of the formulation development process? Ultimately, drug formulation needs to take into account all of the aforementioned components, including final dosage form, in order to maximize patient compliance and pharmacoutility.
This insulation from knowledge of the adjacent steps in the process has a negative effect on the whole development and formulation lifecycle. We owe it to our patients for the future of medicine.
However, with that said, think about this: Top pastry chefs know that how a dessert is offered and displayed has a differential effect on enjoyment. Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.
Neurology 28 January Locwin, B. Drug pricing: Market value. AAPS blog. Developability of biotherapeutics: Computational Approaches. Levitt, S. Freakonomics: A rogue economist explores the hidden side of everything. William Morrow. He also provides advisement to many organizations and boards for a range of business, healthcare, clinical, and patient concerns.
He can be reached at ben. Related Searches. Suggested For You. Each processing step involves several process parameters.
For a given formulation, all processing steps must be thoroughly evaluated so that a robust manufacturing process can be defined. This process usually starts after the formulation is selected, and a larger quantity of API usually is needed. This entire process is usually called manufacturing process development and optimization, and DOE can be applied effectively to optimize this process.
In manufacturing process development, various techniques must be considered for planning experimental designs. A very powerful technique is to develop a process flow diagram which can aid in outlining the sequence of process steps and list pertinent variables and responses of interest at each stage of the development plan. The detail in these diagrams can vary a great deal depending upon the type of formulation being developed.
At each stage of the process, design and analysis ideas can be developed. Once an initial set of designs has been planned, resources such as chemical need or availability for each step can be determined and altered as necessary.
As results from each process step become available, process variables at fixed conditions can be carried forward to later steps. For example, suppose the lowest and highest acceptable load sizes and acceptable blending times have been established from the preblending stage.
At the granulation stage, it is of interest to determine the effects of load size, total water, and the water addition rate on the responses listed in Table VIII. Nonetheless, chemical availability is low and is in greater need at later stages of the process. It is of interest to measure the direct effects of each variable on each of the responses, but it is not as important to determine interactions among the variables. So a previously planned 2 3 factorial design can be reduced to a 2 fractional factorial design to conserve chemical resources.
This type of process can be continued at each stage and even throughout the entire formulation development process. It is advantageous for the research team to plan out the experimental design process for each step of formulation development. The team should examine many factors, including, but not limited to, formulation development objectives, the availability of previous theoretical and experimental results, relevant variables and responses, available resources, and cost.
It should be noted, however, that the process for experimental design throughout all the stages of formulation development cannot be decided upon in one sitting. Every process has its unique challenges, and many different experimental designs and analysis techniques can be applied to address them. It is impossible to provide specific designs that will always be appropriate at each stage.
As the process progresses, results from experimental designs planned for the earlier stages of the formulation development may provide guidance that alters plans made at later stages. When the manufacturing process of a pharmaceutical product is optimized by a systematic approach using DOE, the manufacturing process will be robust and the process understanding will be comprehensive. These results, in turn, will contribute to successful scale-up and process validation, and will ultimately ensure high product quality during routine production.
Design of experiments DOE and statistical analysis have been applied widely to formulation development. Using DOE allows formulation scientists to evaluate all formulation factors in a systematic and timely manner to optimize the formulation and manufacturing process.
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