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Ready to Use Liquid & Lyophilized Formulations

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

We offer end to end pharmaceutical formulation development services of ready to use liquid & lyophilized products for IV, IM and SC ranging from early phase development to clinical supplies for new chemical entities, generics and life cycle extension prod

Intravenous Parenterals Development

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Injectable Solutions

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Etico has highly experienced and skilled research staff to support customers in the area of oncological and non-oncological parenteral product formulation development. Our state of the art laboratory is equipped with isolators to handle potent molecules.

Parenteral Formulation

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Whether your product is a small molecule or a biotech pharmaceutical (protein, peptide or oligonucleotide), PYRAMID can assist you in the design and execution of pre-formulation and formulation development studies that will help define your final drug product formulation.

Intramuscular Parenterals Development

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Injectable Suspensions

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Etico has highly experienced and skilled research staff to support customers in the area of oncological and non-oncological parenteral product formulation development. Our state of the art laboratory is equipped with isolators to handle potent molecules.

Subcutaneous Parenterals Development

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Injectable Emulsions

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Etico has highly experienced and skilled research staff to support customers in the area of oncological and non-oncological parenteral product formulation development. Our state of the art laboratory is equipped with isolators to handle potent molecules.

Parenteral- Sterile Liquid & Lyophilized Forms

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Zenvision Pharma is a Contract Research & Development Organisation, offering a full range of custom designed formulation development services with professional standards. We are committed to innovation and delivering affordable and quality medicines to customers globally within the timeline.

Injectable

API & Drug Product Development >> Formulation Development >> Injectable / Parenteral

Penmix Ltd. has its own top-notch Development Division specialized in developing penicillin and injectable products. In the Development Division, the efficiency of the process is maximized as each steps of the R&D from Planning, Research, Product Development to Regulatory Affairs carried out

Injectable/Parenteral Formulation Development Parenteral preparations are sterile preparations containing one or more active ingredients intended for administration by injection, infusion or implantation into the body. They are packaged in either single-dose or multidose containers. Injectable development may require the use of excipients such as solvents, substances to enhance solubility, suspending agents, buffering agents, substances to make the preparation isotonic with blood, stabilizers or antimicrobial preservatives. The addition of excipients during the sterile injectable formulation development is kept to a minimum. When occupants are used as per standards during sterile injectable development they do not adversely affect the stability, bioavailability, safety or efficacy of the active ingredient(s), or cause toxicity or undue local irritation. There must be no incompatibility between any of the components of the dosage form. Sterile injectable development differs from all other drug dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body, the skin, and mucous membranes. They must be exceptionally pure and free from physical, chemical, and biological contaminants. Parenteral/Injectable Combinations Aseptic development of sterile injectable formulation should preferably take place in equipment operated under positive pressure relative to the surrounding area. Poor cGMP conditions for sterile injectable development can ultimately pose a life-threatening health risk to a patient. Sterile injectable development differs from other dosage form. Parenteral product directly enters into systemic circulation. Parenteral formulation development should be free from any type of pyrogen, micro-organisms and particulate matter. According to 21 CFR 211.25 for CDMOs of sterile injectables, well trained personnel are important and lab personnel should give thought early on to the application itself as well as to its requirements and prepare a checklist or User Requirement Specification (URS). In selecting a sterility testing system, they also need to weigh process risks against the cost benefits. Specifically, it is common practice for a physician to order the addition of a small-volume therapeutic injection (SVI), such as an antibiotic, to large-volume injections (LVIs), such as 1000 mL of 0.9% sodium chloride solution, to avoid the discomfort, for the patient, of a separate injection. Certain aqueous vehicles are recognized officially, due to their valid use in parenterals. Often, they are used as isotonic vehicles to which a drug may be added at the time of administration. The additional osmotic effect of the drug may not be enough to produce any discomfort when administered. Contract development of injectable formulations have a challenge of stability of the drug substance which is another critical point that a formulator requires aseptic techniques to develop pyrogen free injectables. Small volume parenterals (SVP) development requires GMP certified facility with clean rooms and proper documentations. Several parenteral formulation development CDMO requires ICH to be followed. Intravenous injectable development CDMO are GMP compliant facilities, various other services of injectable formulation CDMOs are injectable emulsion development, injectable suspension development, Intravenous (IV) Injectable development, Intravenous Injectable (IM) development and for these vehicles required are Sodium Chloride Injection, Ringer’s Injection, Dextrose Injection, Dextrose and Sodium Chloride Injection, and Lactated Ringer’s Injection. General Guidance for Developing Formulations of Injectable Drugs The final formulation of a parenteral drug product depends on understanding the following factors that dictate the choice of formulation and dosage form. 1. Route of administration—Injections may be administered by such routes as intravenous, subcutaneous, intradermal, intramuscular, intraarticular, intralesional, and intrathecal. The type of dosage form (solution, suspension, etc.) determines the particular route of administration employed. Conversely, the desired route of administration places requirements on the formulation. 2. If the route of administration must be intravenous, sustained release parenteral Depots then only solutions or microemulsions can be the dosage form. If the route of administration is subcutaneous or intramuscular, then the likely type of dosage form is a suspension or other microparticulate delivery system. 3. Pharmacokinetics of the drug—Rates of absorption (for routes of administration other than intravenous or intraarterial), distribution, metabolism, and excretion for a drug have some effect on the selected route of administration and, accordingly, the type of formulation. For example, if the pharmacokinetic profile of a drug is very rapid, modified release dosage formulations may need developed. Sterile Parenteral Formulations CDMOs, the dose of drug and the dosage regimen are affected by pharmacokinetics, so the size (i.e., concentration) of the dose will also influence the type of formulation and amounts of other ingredients in the formulation. Liquids For Sterilization Formulation Development of the drug is distributed quickly from the site injection, complexing agents or viscosity inducing agents may be added to the formulation to retard drug dissolution and transport. 4. Drug solubility—If the drug is insufficiently soluble in water at the required dosage, then the formulation must contain a co-solvent or a solute that sufficiently increases and maintains the drug in solution. If relatively simple formulation additives for injectable emulsion development do not result in a solution, then a dispersed system dosage form must be developed. Solubility also dictates the concentration of drug in the dosage form. 5. Drug stability—If the drug has significant degradation problems in solution, then a freeze-dried or other sterile solid dosage form must be developed. Stability is sometimes affected by drug concentration that, in turn, might affect size and type of packaging system used. For example, if concentration must be low during injectable suspension development, due to stability and/or solubility limitations, then the size of primary container must be larger, and this might preclude the use of syringes, cartridges, and/or smaller vial sizes. CDMO Long Acting Injectables storage conditions might dictate choice of container size, formulation components, and type of container. 6. Compatibility of drug with potential formulation additives and packaging systems—It is well-known that drug-excipient incompatibilities frequently exist. Initial preformulation screening studies are essential to ensure that formulation additives, although possibly solving one problem, will not create another. Stabilizers, such as buffers and antioxidants, although chemically stabilizing the drug in one way, may also catalyze other chemical degradation reactions. Excipients and certain drugs can form insoluble complexes. Impurities in excipients can cause drug degradation reactions. Finding the right fill/finish partner The selection of parenteral CDMO partner is, of course, highly influenced by time and capacity factors. The often lengthy and expensive process of securing drug substance development is heavily influenced by the complexity of selecting and setting up suitable and scalable Injectable development by CDMO. This often results in pharmaceutical or biotech clients having somewhat unrealistic expectations of the cost and time required to find and commission an optimal parenteral formulation development. More experienced innovators have seen the need to obtain external support earlier in the Injectable drug development process, and their strategic relationships are being established based on future needs for later-stage supply. The much larger proportion of prenteral drug development taking place, and the need to be flexible and respond to changing market demands or forecasts, means that the most successful Injectable CDMOs are those that can demonstrate their experience by adapting to their clients’ needs. Small volume parenterals (SVP) development requires GMP certified facility with clean rooms and proper documentations. Several parenteral formulation development CDMO requires ICH to be followed. Intravenous injectable development CDMO are GMP compliant facilities, various other services of injectable formulation CDMOs are injectable emulsion development, injectable suspension development, Intravenous (IV) Injectable development, Intravenous Injectable (IM) development and for these vehicles required are Sodium Chloride Injection, Ringer’s Injection, Dextrose Injection, Dextrose and Sodium Chloride Injection, and Lactated Ringer’s Injection. A flexible approach to contract development of injectable emulsions, and the ability to employ a range of production systems and technologies is also necessary because of the shift from the blockbuster drug model to a focus on small batch sizes and personalized medicines. Parenteral Drugs Sourcing Unless very well funded, biotech firms will always outsource their injetable needs. Even though many biotech drug products are outlicensed to large pharmaceutical companies, having an experienced partner within the supply chain can have a positive impact on the value of the outlicensing deal. In fact, scale-up for some parts of the drug substance production process may be so complex that choosing the right injectable CDMO partner for Phase III trials and commercial supply, may be a considerable asset that adds value to the whole drug product programme. Large Injectable CDMO have different outsourcing strategies. At times, corporate strategy, rather than the specific needs of an individual programme, may be the most influential factor in establishing a firm’s requirements. Such companies tend to outsource Injectable Solutions for established products that may be nearing the end of their marketed life, or that have lower strategic importance, but keep more strategically important Intravenous Parenterals Development in-house. However, there are cases when pharmaceutical companies need to outsource parts of the manufacturing process, such as when they lack specific expertise or when they need to establish a more secure supply chain network through a second partnership. Contract parenteral formulation development companies offer services for Development of Injectable Emulsions, Development of Injectable Suspensions and Development of Injectable Solutions. By using vrious technologies developing injectables require hight quality GMP standards. There is also the added consideration that capital investments may not be the best approach because of the risk that internal capacity may be under-utilised, which is less likely to occur within a typical CDMO’s business model. Parenteral Formulation Development A number of new Injectable development technologies have shown advantages compared with the traditional development. Packaging technologies like Blow-fill-seal (BFS) technology avoids the use of glass itself and reduces the risk of particulate contamination as the container is formed, filled and sealed very quickly within a highly controllable space. Formulation, development and evaluation of injectable formulation for an injectable development CDMO is investing heavily in new technologies while expanding its partnerships and facilities in the fill/finish area by obtaining extra capacity and a wider geographical spread, ultimately driving the technology development for this transformation. The parenteral CDMOs also introduced advanced technologies for Subcutaneous Parenterals Development the delivery of small-molecule and biologic drugs via respiratory, ophthalmic and injectable routes through both BFS unit dose technology and prefilled syringes. Improving patient compliance is becoming increasingly important in evaluating the success of new drug development. Injectable treatments and excipient Selection In Parenteral Formulation Development that are easy to use and suitable for self-administration by patients are continuing to transform the fill/finish market. Parenteral formulation development and Auto-injectors and pens, portable devices to deliver high-viscosity formulations and new devices for intramuscular and intravenous dosing are also having an impact. With the extra staff that may be required to handle serialization, and aggregation equipment and systems, this could have a far-reaching impact on the daily operations of companies. Formulation and development of parenterals requires GMP facility.They will have to decide whether to use an inline solution or an offline solution, which will ultimately be driven by the volume of product. Formulation Development of Parenteral Products. Solubilizing Systems for Parenteral Formulation Development. Injectable Solutions with the requirement for appropriate information technology infrastructure also needs to be taken into account, with interfaces between number range management (NRM) systems being held in the cloud, and automated data transfer between the CMO or CDMO, the NRM and the customer being possible. Intramuscular Parenterals Development. Contract development injectable formulations has a challenge of stability of the drug substance which is another critical point that a formulator. CDMO sterile injectable requires aseptic techniques to develop the injectables pyrogen free. Small volume parenterals (SVP) development requires GMP certified facility with clean rooms and proper documentations. Several parenteral preparation development requires ICH to be followed. Intravenous injectable development CDMO are GMP compliant facilities, various other injectable CDMOs are injectable emulsion development, injectable suspension development. The main challenge of all the different sterile injectable development forms is to achieve a good compatibility of the drug substances with the excipients (no formation of new impurities either by degradation of the drug substance or formation of new chemical entity between the drug substance and the excipients) as well as the parenteral preparations compatibility of the preparations with the primary container (no leachable or adsorption to container). With regards to development of injectable solutions and injectable emulsions CDMO, the drug substances should be soluble and remain soluble during the entire shelf-life of the drug products. When drug substances are not soluble, dissolution can be achieved by the use of co-solvents, surfactants, or a soluble pro-drug, or eventually the use of solubility enhancers such as cyclodextrins thanks to the formation of inclusion complex. Aseptic development of sterile injectable formulation should preferably take place in equipment operated under positive pressure relative to the surrounding area. Control of contamination and cross contamination for the sterile injectable development plays important role by design consideration. Poor cGMP conditions for sterile injectable development can ultimately pose a life-threatening health risk to a patient. Sterile injectable development differs from other dosage form. Parenteral product directly enters into systemic circulation. Parenteral formulation development should be free from any type of pyrogen, micro-organisms and particulate matter. According to 21 CFR 211.25 for CDMOs of sterile injectables, welltrained personnel are important and lab personnel should give thought early on to the application itself as well as to its requirements and prepare a checklist or User Requirement Specification (URS). In selecting a sterility testing system, they also need to weigh process risks against the cost benefits.

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